Preview
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
Exhibit H
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
HSS HIM MRO Ford, Patrick James
535 East 70th Street MRN: 2005536, DOB: 211911980, Sex: M
HSS NEW YORK NY 100214823 Adm: 11l13l202j,DlC:1111712020
Oo Note bv Cunninoham. Matthew E- MD at'l1l13l2020 9:24 AM
Author: Cunningham, Matthew E, MD Service: Orthopedic Surgery Author Type: Physician
Filed: 1 111312020 7:29 PM Date of Service: 1111312020 9:24 AM Status:Signed
Editor: Cunningham, Matthew E, MD (Physician)
HOSPITAL
FOR
SPECIAL
SURGERY
Hos ita
PATIENT NAME: Patrick Ford
MRN:2005536
PROCEDURE DATE: 1 1 I 13I2O2O
SURGERY START/END: 9:24am to 6:30pm
ATTENDING SURGEON: Matthew E. Cunningham MD PhD
CO.SU RGEON : Surgeon(s):
Dowdell, James E lll, MD
Cunningham, Matthew E, MD
Agrusa, Christopher, MD
ASSISTANT: Clark, N.
PRELIMINARY DIAGNOSIS:
1. Lumbar spondylolisthesis (L3-5, posterior)
2. Bertolotti's Syndrome
3. Low back pain with dominant right sciatica
4. Lumbar radiculopathy
POSTOPERATIVE DIAGNOSIS:
1. Lumbar spondylolisthesis (L3-5, posterior)
2. Bertolotti's Syndrome
3. Low back pain with dominant right sciatica
4. Lumbar radiculopathy
NAME OF OPERATION:
1 . Anterior lumbar interbody spinal fusion, L3l4 & L4l5
2. Placement of intervertebral disc space cages/spacers, L3/4 & L4l5
3. Posterior spinal segmental instrumentation, L3-S1
4. Posterolateral spine fusion, L5/S1
FINDINGS: posterior lumbar spondylolisthesis Lsl4 & L4l5, incomplete spontaneous arthrodesis through the
TP's of L5 & S1
ANESTHESIA: general endotracheal;Anesthesiologist: Singleton, Michael, MD
ANTIBIOTIGS: lV prophylactic antibiotic given within t hour of incision was vancomcin
Generated on 12129120 1:03 PM
42 CFR part 2 prohibits unauthorized
disclosure of these records.
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
HSS HIM MRO Ford, Patrick James
Street
535 East 70th MRN: 2005536, DOB: 211911980, Sex: M
NEW YORK NY 100214823 Adm: 1111312020,DlC:1111712020
Op Note bv Cunninoham. Matthew E. MD at 111131202O 9 :24 AM (continued)
ANTIFIBRINOLYTIC: Tranexamic Acid
IMPLANTS:
lmplant Name Type lnv. ltem Serial Manufacturer Lot LRB No. Action
No. No. Used
GRAFT BONE GRAFT MCK6B17 Medtronic Anter 1 lmplanted
26MM lBMM BONE 26MM AAD Spine - Div ior
INFUSE 18MM Medtroni
LGSPINE BVN INFUSE
CLGN RHBMP-2 LGSPINE
- SMCK68,17AAD BVN CLGN
- LOG470B13 RHBMP-2
4WEB 36W X 4Web D011 Anter 1 lmplanted
24D 12 DEG 14 ior
MM INTERBODY
4WEB 36W X 4Web D0'10 Anter 1 lmplanted
24D 12 DEG 14 ior
MM INTERBODY
GRAFTON GRAFTON A45066- Medtronic SD Anter 1 lmplanted
2.5CMX5CM 2.5CMX5CM 018 USA lnc ior
MATRIX PLF - MATRIX PLF
sA45066-018 -
LOG470B1 3
BONE CHIPS BONE CHIPS 00219065 Musculoskeleta Anter 1 lmplanted
CANCELLOUS CANCELLOU 941033 lTransplant tor
sCC FD - S sCC FD Fou
s0021 9065941 03
3 - 1OG47081 3
SCREW 5.5 X SCREW 5.5 X Globus Medical Anter 1 lmplanted
sOMM CANN sOMM CANN ior
MOD CREOAMP MOD
- s - LoG470B13 CREOAMP
SCREW 6.5 X SCREW 6.5 X Globus Medical Anter 1 lmplanted
4OMM CANN 4OMM CANN ror
MOD CREOAMP MOD
- s - 1oG470813 CREOAMP
SCREW 6.5 X SCREW 6.5 X Globus Medical Anter 1 Wasted
sOMM CANN sOMM CANN ior
MOD CREOAMP MOD
- s - 1oG470813 CREOAMP
SCREW 7.5 X SCREW 7.5 X Globus Medical Anter 2 lmplanted
35MM CANN 35MM CANN ior
MOD CREOAMP MOD
- s - 1oG470813 CREOAMP
SCREW 7.5 X SCREW 7.5 X Globus Medical Anter 1 lmplanted
sOMM CANN sOMM CANN tor
MOD CREOAMP MOD
- s - LoG470B13 CREOAMP
Generated on 12129120 1:03 PM
42 CFR paft 2 prohibits unauthorized
disclosure of these records.
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
HSS HIM MRO Ford, Patrick James
Street
535 East 70th MRN: 2005536, DOB: 211911980, Sex: M
HSS NEW YORK NY 100214823 Adm: 11l13l202j,DlC:1111712020
Oo Note bv Cunninoham. Matthew E. MD at 1111312020 9:24 AM (continued)
CREO MIS CREO MIS Globus Medical Anter 6 lmplanted
LOCKING CAP - LOCKING ior
s - 1oG470813 CAP
CREO MIS CREO MIS Globus Medical Anter 6 lmplanted
MODULAR MODULAR ior
POLYAXIAL POLYAXIAL
TULIP 30MM TULip 30mm
REDUCTION - S reduction
- 1OG470813
ROD CREO MIS ROD CREO Globus Medical Anter 1 lmplanted
5.5MM CRVD TI MIS 5.5MM ior
ALLOY 6OMM - S CRVD TI
- LOG470B13 ALLoy 60mm
ROD CREO MIS ROD CREO Globus Medical Anter 1 lmplanted
5.5MM CRVD TI MIS 5.5MM tor
ALLOY ,IOOMM - CRVD TI
S - LOG470B13 ALLoy 100mm
ROD CREO MIS ROD CREO Globus Medical Anter 1 lmplanted
5.5MM CRVD TI MIS 5.5MM ior
ALLOY 11OMM - CRVD TI
S - 1OG470813 ALLoy 110mm
SCREW 5.5 X SCREW 5.5 X Globus Medical Anter 1 Wasted
sOMM CANN sOMM CANN ior
MOD CREOAMP MOD
- LOG47O813 CREOAMP
SCREW 6.5 X SCREW 6.5 X Globus Medical Anter 1 lmplanted
sOMM CANN sOMM CANN ior
MOD CREOAMP MOD
-S -1OG470813 CREOAMP
CREO MIS CREO MIS Globus Medical Anter 2 Wasted
LOCKING CAP - LOCKING ior
s - 1oG470813 CAP
CREO MIS CREO MIS Globus Medical Anter 2 Wasted
MODULAR MODULAR ior
POLYAXIAL POLYAXIAL
TULIP 30MM TULip 30mm
REDUCTION - S reduction
- 1OG470813
Vancomycin powder (1 gr), surgiflo
PATHOLOGY/GULTURES: None
ESTIMATED BLOOD LOSS:500 mL
URINE OUTPUT: Foley catheter used, 2000 mL
INTRAVENOUS FLUIDS: 4500 mL LR, 170 mL Cell Saver, 500 mL 5% Albumin
DRAINS: None
COMPLICATIONS: There were no intraoperative nor immediate postoperative complications noted.
COUNTS: All sponge and needle counts were correct at the end of the case.
Generated on 12129120 1:03 PM
42 CFR part 2 prohibits unauthorized
disclosure of these records.
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
HSS HIM MRO Ford, Patrick James
Street
535 East 70th MRN: 2005536, DOB: 211511980, Sex: M
HSS NEW YORK NY 100214823 Adm: 1111312020,DlC:1111712020
Oo Note bv Cunninoham. E. MD at 11/1312020 9:24 AM (continued)
NEUROMONITORING: No sustained changes were noted throughout the procedure.
POSITIONING: Supine "DaVinci" for the ALIF, Prone on a Jackson
VISUAL MAGNIFICATION: Surgical loupes were used.
CLOSURE: Multilayer closure, absorbable sutures used throughout.
DISPOSITION: The patient was lightened from anesthesia and was able to demonstrate active dorsiflexion and
plantarflexion of the toes and ankles bilaterally. The patient was then uneventfully extubated in the operating
room, and was transported to the recovery room in hemodynamically stable condition.
ATTESTATION: lwas present during the entire procedure.
lndications:
Patrick James Ford is a 40 y.o. male with prior lumbar decompression x2 now with recurrent LBP and
dominant right leg pain in the setting of L5/S1 Bertolotti's, posterior spondylolisthesis L3l4 & L4l5 that has not
durably responded to non-operative management. He was educated for the expected improvement in his
symptoms with (indirect) decompression (distraction cage placement L3-5) and fusion (L3-S1), and wished to
proceed with the surgical intervention.
Risks and benefits for the procedure were reviewed, including: bleeding potentially requiring transfusion,
infection of the wound potentially requiring further surgery to clean the wound, epidural hematoma or damage
to the local nerves or spinal cord resulting in postoperative neurological symptoms, damage to the dural
meninges requiring immediate repair and potential for postoperative positional headaches, failure of the
surgery to control the symptoms, and further degeneration of the spine requiring additional surgery in the
future. lt was explained that intraoperative neurological monitoring and fluoroscopy/x-rays would be used to
minimize risks for permanent neurological injury and to definitively identify the spine segmentation and implant
placement. lntermediate and long term complications were also reviewed, and included: risks for failure of the
fusion to heal, disk herniation or degeneration above or below the fusion potentially causing pain or
neurological injury and requiring future revision surgery, fracture of the fusion or other vertebrae, loss of fixation
of the implants to the bones, fracture of the implants, and accelerated joint degeneration above or below the
fusion resulting in pain or deformity and possible requirement for further surgery in the future. Regarding
specifics of the anterior exposure, risks reviewed included damage to structures in the retroperitoneum
including the ureters and great blood vessels, thigh discomfort or weakness due to the dissection, and bowel
problems including postoperative ileus. Rare complications were also described, including iatrogenic disk
herniation and sub-optimally placed intervertebral disk spacers that could contribute to neurological symptoms
of pain, numbness or weakness, both of which are minimized by use of intra-operative neuromonitoring and
fluoroscopy/x-rays. Medical complications were reviewed, including but not limited to: heart attack, stroke,
intravascular blood clots, pulmonary embolus, pneumonia, and urinary tract infection. The patient understood,
and wished to proceed.
PROCEDURE:
Holding area events. The patient was greeted in the pre-operative holding area, personal identifier information
was solicited, and a marker was used to initial his hospital identification wristband to indicate that proper
identification had been confirmed, and for placement of the surgeon's initials at the surgical site. Risks and
benefits were again reviewed with him, and informed consent form was obtained. The patient was then
transported to the operating room.
Pre-positioning events. Upon delivery to the operating room, he was assisted with transfer onto the operating
room table and was given intravenous sedation by the anesthesiologist. An endotracheal tube was then
placed, and general anesthesia was induced. Further intravascular access was obtained, preoperative
prophvlactic lV antibiotics were delivered within 60 m inutes of surqical incision, and neuromonitorinq leads
Generated on 12129120 'l:03 PM
42 CFR part 2 prohibits unauthorized
disclosure of these records.
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
HSS HIM MRO Ford, Patrick James
Street
535 East 70th MRN:2005536, DOB: 211911980, Sex: M
HSS NEW YORK NY 10021-4823 Adm: 1111312020, DIC: 1111712020
Op Note by Cunninsham, Matthew E, MD at1111312020 9:24 AM (continued)
were placed on bilateral upper and lower extremities.
The patient was positioned, prepped and draped. This will be described in greater detail in a separate operative
note by DrAgrusa. He was optimized on the table in supine position, referenced to the pedestalof the table, in
order to maximize fluoroscopic access. Bony prominences on the upper and lower extremities were assured
for proper padding, the hips were placed into neutral extension simulating standing posture, and 10-10 drapes
were used to define the surgicalzone. The patient was then prepped and draped in the standard sterile fashion
A surgical "time out" was performed, along with the surgical checklist, and the intended procedure was
reviewed.
The L3/4 level was exposed in a retroperitoneal plane and spine segmentation was confirmed. Dr Agrusa
performed the approach, and will describe the procedure in a separate, detailed operative note. Segmentation
was confirmed with a pituitary clamp grasping the anterior annulus fibers of the L3/4 disc space, and
fluoroscopic imaging. The wound was copiously irrigated with antibiotic-containing irrigant.
The L3/4 disc space was prepared. Electrocautery was used to complete the anterior annulectomy, and the
disc contents were debrided with variously sized loop curettes, straight and angled curettes, and pituitary
rongeurs. The wound was copiously irrigated with antibiotic-containing irrigant.
The 314 disc space was sized for an intervertebral disc space spacer/implant. Sizers starting at 8mm height
and mid-range lordosis were then increased in dimensions until optimal fit and stability were obtaineded. The
14mm height x 36mm width x 24mm depth (medium footprint) and 12 degree lordosis trial was found to be an
ideal fit. The wound was copiously irrigated with antibiotic-containing irrigant.
The L3/4 intervertebral implant was placed and the L3/4 anterior spinal fusion was performed. The final implant
selected above was packed with BMP-loaded sponges from a BMP-2 kit (Medtronic, lnfuse), and the cage was
tapped into position under direct vision. The cage was countersunk referenced to the anterior L3 & L4 vertebral
endplates by 1-2mm. Placement of the cage was confirmed with fluoroscopy, and was found to have been
placed as was intended. The wound was copiously irrigated with antibiotic-containing irrigant.
The L4l5 levelwas then fused and IVD cage placed. Procedure was performed exactly as described above,
with placement of identical cage, and interrogation with fluoroscopy AP & Lateral, and followed by copious
irrigation.
The wound was closed in layers. The patient was then transferred back to care of Dr Agrusa, and description
of the wound closure will be provided in a separate operative note.
The anesthesiologist then assessed the patient, and deemed him stable to proceed tot he posterior
instru mentation & fusion.
The patient was re-positioned, prepped and draped. He was then log-rolled onto a second operating room
table with a prone surgical positioning frame (see BON above). The bolsters were optimized for position on the
anterior-superior iliac spines of the pelvis, and to support the anterior chest wall, bilaterally. The bolsters on
the chest were optimized to support the thorax during the procedure while allowing pressure-free exit of the
axillary contents bilaterally. Bony prominences on the upper and lower extremities were assured for proper
padding, the hips were placed into neutral extension simulating standing posture, and 10-10 drapes were used
to define the surqical zone. The patient was then prepped and draoed in the standard sterile fashion
Generated on 12129120 1:03 PM
42 CFR part 2 prohibits unauthorized
disclosure of these records.
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
HSS HIM MRO Ford, Patrick James
Street
535 East 70th MRN: 2005536, DOB: 211911980, Sex: M
Hgs NEW YORK NY 10021-4823 Adm: 1111312020, DIC: 1111712020
Op Note bv Cunninqham. Matthew E. MD a|1111312020 9:24 AM continued
A surgical "time out" was performed, along with the surgical checklist, and the intended procedure was
reviewed.
The Globus robot was initialized. This will be described in more detail in Dr Dowdell's note, but briefly: a
"pitchfork" bone pin was driven into the right posterior superior iliac spine (PSIS) through a 5mm incision
created with a #15 blade. Temporary and procedure arrays were attached to the pitchfork bone pin. A
separate short modified steimann pin with fiducial reflector ballwas driven into the left PSIS through a second
5mm incision. The video multidetector array arm was used to register all of the NAV instruments, and was also
used to register the patient and pelvis fiducial/arrays. A 3-D Zheim spin was then performed to register the
fiducials & arrays to the patient's lumbar spine. A "chicken foot" was used to check for adequate registration by
checking against the fiducials and bony landmarks.
The superficial dissection was performed, and segmentation of the spine confirmed. BilateralWiltse incisions
were designed using the Globus robotic arm to allow placement of the L3-Sl screws with minimal soft tissue
counter-force generation. Bilateral incisions were created with a surgical scalpel, and meticulous hemostasis
was obtained and maintained throughout the procedure using electrocautery. Dissection continued in both a
sharp and bluntfashion down tothe levelof thefascia. Fasciawas incised and dissection then continued
down to the junction of the lateral facet joints and transverse process junction. Speical attention was placed to
expose the LS/S1 dorsal lateral posterior elements (enlarged L5 transverse process and S1 alae)to maximally
allow for decortication and graft placement for the intended posterior/posterolateral fusion.Segmentation of the
spine was confirmed with the robot registration, and with the NAV & "chicken foot". The wound was copiously
irrigated with antibiotic containing sterile irrigant.
Pedicle screws were placed. This will be described in detail in Dr Dowdell's note. The Globus Robot was used
to place screws L3-S1. The wound was again copiously irrigated with antibiotic containing sterile irrigant.
The rods were placed, and the spine deformity was corrected. The "minimally invasive" (end capture for
percutaneous manipulation) pre-bent cylindrical 5.5mm Ti rods were threaded distally to proximally through the
screw towers, were captured to the pedicle screws with set screws, and were provisionally tightened. The
wounds were copiously irrigated with antibiotic-containing sterile irrigant. AP and Lateralfluoroscopic images
were obtained on the table after the correction to assess the deformity reduction and confirm implant
status/placement. The implants were then all finally tightened, according to the manufacturer's
recommendations. The wound was copiously irrigated with antibiotic-containing sterile irrigant.
The posterior/posterolateral fusion at L5/S1 was performed. Within the fusion zone, a high speed burr was
used to decorticate the posterior elements including the sacral alae, L5 transverse processes, lateal pars
interarticularis, and lateral facet joint remnants, bilaterally. Bone graft materials were then placed within the
prepared fusion bed, including local bone (dust)autograft, a BMP sponge (1 of the 6 from a large kit, on each
side), and DBM bone graft extender. A gram of vancomycin powder was split and placed over the bone graft
material, and the decision was made to close the wound.
The wound was closed in layers. The closure of the wound will be described in detail in Dr Dowdell's note,
multilayer closure with PDS, and Prineo Dermabond on the skin. The surgical drapes were then taken down,
and all the dressing materials were attached to his back using a bio-occlusive barrier dressing.
He was then rolled to supine position into a hospital bed and was lightened from anesthesia.
He was able to demonstrate active dorsiflexion and plantar flexion of the toes and ankles bilaterallv. and was
Generated on 12129120 1:03 PM
42 CFR part 2 prohibits unauthorized
disclosure of these records.
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
HSS HIM MRO Ford, Patrick James
535 East 70th Street MRN: 2005536, DOB: 211911980, Sex: M
HSS NEW YORK NY '100214823 Adm:1111312020, D/C: '1111712020
Op Note bv Cunninaham. Matthew E. MD at1ll'l3l202} AM (continued)
then uneventfully extubated and was transported to the recovery room in hemodynamically stable condition.
All sponge and needle counts were correct at the end of the case.
There were no sustained changes of neuromonitoring throughout the procedure.
He was planned to have the prophylactic lV antibiotics discontinued within 24 hours postoperatively.
He was planned to receive appropriate DVT/PE prophylaxis postoperatively.
I was present throughout the entire procedure.
Op Note bv Dowdell. James E lll. MD at1111312020 9:24
Author: Dowdell, James E lll, MD Service: Orthopedic Surgery Author Type: Physician
Filed: 1 111312020 9:36 PM Date of Service: 1111312020 9:24 AM Status: Signed
Editor: Dowdell, James E lll, MD (Physician)
THE HOSPITAL FOR SPECIAL SURGERY
OPERATIVE RECORD
Patient Name: Patrick James Ford
MR#: 2005536
Date: 1111312020
ATTENDING SURGEON: James Dowdell, MD
OPERATING SURGEON: James DowdeII, MD
Go.Surgeons: Matthew Cunningham, MD
Christopher Agrusa, MD (Vascular)
ASSISTANT: Nick Clark, MD
PREOPERATIVE DIAGNOSIS
1. Lumbar spondylolisthesis (L3-5, posterior)
2. Bertolotti's Syndrome
3. Low back pain with dominant right sciatica
4. Lumbar radiculopathy
POSTOPERATIVE DIAGNOSIS:
1. Lumbar spondylolisthesis (L3-5, posterior)
2. Bertolotti's Syndrome
3. Low back pain with dominant right sciatica
4. Lumbar radiculopathy
Generated on 12129120 1:03 PM
42 CFR part 2 prohibits unauthorized
disclosure of these records.
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
HSS HIM MRO Ford, Patrick James
Street
535 East 70th MRN: 2005536, DOB: 211911980, Sex: M
Hgs NEW YORK NY'100214823 Adm: 111'1312020, DIC: 1111712020
Oo Note bv Dowdell. James E lll. MD at1ll13l2020 9:24 (continued)
NAME OF OPERATION:
1 . Anterior lumbar interbody spinal fusion, L3l4 & L4l5
2. Placement of intervertebral disc space cages/spacers, L3/4 & L4l5
3. Posterior spinal segmental instrumentation, L3-S1
4. Posterolateral spine fusion, Ls/S'1
ANESTHESIA: GENERAL ENDOTRACHEAL.
Anesthesiologist: Michael Singleton, MD
lmplants:
lmplant Name Type lnv. ltem Serial No.Lot LRB No.
Manufacturer Action
No. Use
d
GRAFT BONE GRAFT MCK6817AAD Medtronic Anterior 1 lmplanted
26MM 18MM BONE 26MM Spine - Div
INFUSE 18MM Medtroni
LGSPINE BVN INFUSE
CLGN RHBMP-2 LGSPINE
- SMCK6B1TAAD BVN CLGN
- LOG47OB13 RHBMP-2
4WEB 36W X 4Web D011 Anterior 'l lmplanted
24D 12 DEG 14
MM INTERBODY
4WEB36WX 4Web D010 Anterior 1 lmplanted
24D 12 DEG 14
MM INTERBODY
GRAFTON GRAFTON A45066-018 Medtronic SD Anterior 1 lmplanted
2.5CMX5CM 2.5CMX5CM USA lnc
MATRIX PLF - MATRIX PLF
sA45066-018 -
1OG470813
BONE CHIPS BONE CHIPS 0021906594103 Musculoskeleta Anterior 1 lmplanted
CANCELLOUS CANCELLOU 3 lTransplant
sCC FD - S sCC FD Fou
s0021 906594103
3 - 1OG470813
SCREW 5.5 X SCREW 5.5 X Globus Medical Anterior 1 lmplanted
sOMM CANN sOMM CANN
MOD CREOAMP MOD
-S -1OG470813 CREOAMP
SCREW 6.5 X SCREW 6.5 X Globus Medical Anterior 1 lmplanted
4OMM CANN 4OMM CANN
MOD CREOAMP MOD
-S -1OG470813 CREOAMP
SCREW 6.5 X SCREW 6.5 X Globus Medical Anterior 1 Wasted
Generated on 12129120 1:03 PM
42 CFR part 2 prohibits unauthorized
disclosure of these records.
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
HSS HIM MRO Ford, Patrick James
535 East 70th Street MRN: 2005536, DOB: 211911980, Sex: M
HSS NEW YORK NY 100214823 Adm: 1111312020, DIC: 1111712020
Oo Note bv Dowdell. James E lll. MD at1111312020 9:24 (continued)
sOMM CANN sOMM CANN
MOD CREOAMP MOD
- s - 1oG470813 CREOAMP
SCREW 7.5 X SCREW 7.5 X Globus Medical Anterior 2 lmplanted
35MM CANN 35MM CANN
MOD CREOAMP MOD
- s - 1oG470813 CREOAMP
SCREW 7.5 X SCREW 7.5 X Globus Medical Anterior 1 lmplanted
sOMM CANN sOMM CANN
MOD CREOAMP MOD
- s - 1oG470813 CREOAMP
CREO MIS CREO MIS Globus Medical Anterior 6 lmplanted
LOCKING CAP - LOCKING
s - 1oG470813 CAP
CREO MIS CREO MIS Globus Medical Anterior 6 lmplanted
MODULAR MODULAR
POLYAXIAL POLYAXIAL
TULIP 3OMM TULip 30mm
REDUCTION - S reduction
- 1OG470813
ROD CREO MIS ROD CREO Globus Medical Anterior 1 lmplanted
5.5MM CRVD TI MIS 5.5MM
ALLOY 6OMM - S CRVD TI
- 1OG470813 ALLoy 60mm
ROD CREO MIS ROD CREO Globus Medical Anterior 1 lmplanted
5.5MM CRVD TI MIS 5.5MM
ALLOY lOOMM - CRVD TI
s - 1oG470813 ALLoy
100mm
ROD CREO MIS ROD CREO Globus Medical Anterior 1 lmplanted
5.5MM CRVD TI MIS 5.5MM
ALLOY 11OMM - CRVD TI
s - LOG470B13 ALLoy
1 1Omm
SCREW 5.5 X SCREW 5.5 X Globus Medical Anterior 't Wasted
sOMM CANN sOMM CANN
MOD CREOAMP MOD
- 1OG470813 CREOAMP
SCREW 6.5 X SCREW 6.5 X Globus Medical Anterior 1 lmplanted
SOMM CANN sOMM CANN
MOD CREOAMP MOD
- s - 1oG470813 CREOAMP
CREO MIS CREO MIS Globus Medical Anterior 2 Wasted
LOCKING CAP - LOCKING
s - 1oG470813 CAP
CREO MIS CREO MIS Globus Medical Anterior 2 Wasted
MODULAR MODULAR
POLYAXIAL POLYAXIAL
Generated on 12129120 1:03 PM
42 CFR pad 2 prohibits unauthorized
disclosure of these records.
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
HSS HIM MRO Ford, Patrick James
535 East 70th Street MRN: 2005536, DOB: 211911980, Sex: M
Hgs NEW YORK NY 1002'14823 Adm:1111312020, D/C: 1111712020
Oo Note bv Dowdell. James E lll. MD at 1111312020 9:24 (continued)
TULIP 3OMM TULip 30mm
REDUCTION - S reduction
- LOG470B13
PATHOLOGY/GULTURES: None
ESTIMATED BLOOD LOSS:500 mL
URINE OUTPUT: Foley catheter used, 2000 mL
INTRAVENOUS FLUIDS:4500 mL LR, 170 mL Cell Saver, 500 mL 5% Albumin
DRAINS: None
COMPLICATIONS: There were no intraoperative nor immediate postoperative complications noted
GOUNTS: All sponge and needle counts were correct at the end of the case.
NEUROMONITORING: No sustained changes were noted throughout the procedure.
POSITIONING: Supine "DaVinci" for the ALIF, Prone on a Jackson
VISUAL MAGNIFICATION: Surgical loupes were used.
CLOSURE: Multilayer closure, absorbable sutures used throughout. NO VICRYL used, PDS Suture used for
all layers
DISPOSITION: The patient was lightened from anesthesia and was able to demonstrate active dorsiflexion and
plantarflexion of the toes and ankles bilaterally. The patient was then uneventfully extubated in the operating
room, and was transported to the recovery room in hemodynamically stable condition.
FINDf NGS: posterior lumbar spondylolisthesis L3l4 & L4l5, incomplete spontaneous arthrodesis through the
TP's of L5 & 51, spondylolysis of L5 pars
INDICATIONS FOR PROCEDURE:
Patrick James Ford is a 40 y.o. male with prior lumbar decompression x2 now with recurrent LBP and
dominant right leg pain in the setting of L5/S1 Bertolotti's, posterior spondylolisthesis L3/4 & L4l5 that has not
durably responded to non-operative management. He was educated for the expected improvement in
his symptoms with (indirect) decompression (distraction cage placement L3-5) and fusion (L3-Sl ), and wished
to proceed with the surgical intervention.
Risks and benefits for the procedure were reviewed, including: bleeding potentially requiring transfusion,
infection of the wound potentially requiring further surgery to clean the wound, epidural hematoma or damage
to the local nerves or spinal cord resulting in postoperative neurological symptoms, damage to the dural
Generated on 12129120 1:03 PM
42 CFR part 2 prohibits unauthorized
disclosure of these records.
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
HSS HIM MRO Ford, Patrick James
535 East 70th Street MRN: 2005536, DOB: 211911980, Sex: M
HSS NEW YORK NY 1002'1 4823 Adm: 1111312020, DIC: 11 117 12020
Oo Note bv Dowdell. James E lll. MD at 1111312020 9:24 (continued)
meninges requiring immediate repair and potential for postoperative positional headaches, failure of the
surgery to control the symptoms, and further degeneration of the spine requiring additional surgery in the
future. lt was explained that intraoperative neurological monitoring and fluoroscopy/x-rays would be used to
minimize risks for permanent neurological injury and to definitively identify the spine segmentation and implant
placement. lntermediate and long term complications were also reviewed, and included: risks for failure of the
fusion to heal, disk herniation or degeneration above or below the fusion potentially causing pain or
neurological injury and requiring future revision surgery, fracture of the fusion or other vertebrae, loss of fixation
of the implants to the bones, fracture of the implants, and accelerated joint degeneration above or below the
fusion resulting in pain or deformity and possible requirement for further surgery in the future. Regarding
specifics of the anterior exposure, risks reviewed included damage to structures in the retroperitoneum
including the ureters and great blood vessels, thigh discomfort or weakness due to the dissection, and bowel
problems including postoperative ileus. Rare complications were also described, including iatrogenic disk
herniation and sub-optimally placed intervertebral disk spacers that could contribute to neurological symptoms
of pain, numbness or weakness, both of which are minimized by use of intra-operative neuromonitoring and
fluoroscopy/x-rays. Medical complications were reviewed, including but not limited to: heart attack, stroke,
intravascular blood clots, pulmonary embolus, pneumonia, and urinary tract infection. The patient understood,
and wished to proceed.
PROCEDURE:
Holding area events. The patient was greeted in the pre-operative holding area, personal identifier information
was solicited, and a marker was used to initial his hospital identification wristband to indicate that proper
identification had been confirmed, and for placement of the surgeon's initials at the surgical site. We made a
mark on both his abdomen and his back. Risks and benefits were again reviewed with him, and informed
consent form was obtained. The patient was then transported to the operating room.
Pre-positioning events. Upon delivery to the operating room, he was assisted with transfer onto the operating
room table and was given intravenous sedation by the anesthesiologist. An endotracheal tube was then
placed, and general anesthesia was induced. He was given TAP blocks at this time for postoperative pain
relief. Further intravascular access was obtained, preoperative prophylactic lV antibiotics were delivered within
60 minutes of surgical incision, and neuromonitoring leads were placed on bilateral upper and lower
extremities.
The patient was positioned, prepped and draped. He was placed in the Da Vinci position. We obtained x-rays
to ensure that we could adequately reach all the disc spaces of interest with the current positioning.
Preoperative x-rays deemed we would be able to reach the appropriate levels. this will be described in greater
detail in a separate operative note by Dr Agrusa. He was optimized on the table in supine position, referenced
to the pedestal of the table, in order to maximize fluoroscopic access. Bony prominences on the upper and
lower extremities were assured for proper padding, the hips were placed into neutral extension simulating
standing posture, and 10-10 drapes were used to define the surgicalzone. The patient was then prepped and
draped in the standard sterile fashion
A surgical "time out" was performed, along with the surgical checklist, and the intended procedure was
reviewed.
The L3/4 levelwas exposed in a retroperitoneal plane and spine segmentation was confirmed. Dr
Agrusa performed the approach, and will describe the procedure in a separate, detailed operative note.
Generated on 12129120 1:03 PM
42 CFR pad 2 prohibits unauthorized
disclosure of these records.
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
HSS HIM MRO Ford, Patrick James
535 East 70th Street MRN: 2005536, DOB: 211911980, Sex: M
HSS NEW YORK NY 1002'14823 Adm: 1111312020,D|C:1111712020
Op Note by Dowdell, James E lll, MD at1111312020 9:24 AM (continued)
Segmentation was confirmed with a pituitary clamp grasping the anterior annulus fibers of the L3/4 disc space,
and fluoroscopic imaging. The wound was copiously irrigated with antibiotic-containing irrigant.
The L3/4 disc space was prepared. Electrocautery was used to complete the anterior annulectomy, and the
disc contents were debrided with variously sized loop curettes, straight and angled curettes, and pituitary
rongeurs. The wound was copiously irrigated with antibiotic-containing irrigant. The 3/4 disc space was sized
for an intervertebral disc space spacer/implant. Sizers starting at 8mm height and mid-range lordosis were then
increased in dimensions until optimal fit and stability were obtaineded. The 14mm height x 36mm width
x24mm depth (medium footprint) and 12 degree lordosis trialwas found to be an idealfit. The wound was
copiously irrigated with antibiotic-containing irrigant. The L3/4 intervertebral implant was placed and the
L3/4 anterior spinalfusion was performed. The final implant selected above was packed wilh BMP-loaded
sponges from a BMP-2 kit (Medtronic, lnfuse), and the cage was tapped into position under direct vision. The
cage was countersunk referenced to the anterior L3 & L4 vertebral endplates by 1-2mm. Placement of the cage
was confirmed with fluoroscopy, and was found to have been placed as was intended. The wound was
copiously irrigated with antibiotic-containing irrigant.
The L4l5 levelwas then fused and IVD cage placed. Procedure was performed exactly as described above,
with placement of identical cage, and interrogation with fluoroscopy AP & Lateral, and followed by copious
irrigation.
The wound was closed in layers. The patient was then transferred back to care of Dr Agrusa, and description
of the wound closure will be provided in a separate operative note.
The anesthesiologist then assessed the patient, and deemed him stable to proceed tot he posterior
instrumentation & fusion. The patient was re-positioned, prepped and draped. He was then log-rolled onto a
second operating room table with a prone surgical positioning frame (see BON above). The bolsters were
optimized for position on the anterior-superior iliac spines of the pelvis, and to support the anterior chest wall,
bilaterally. The bolsters on the chest were optimized to support the thorax during the procedure while allowing
pressure-free exit of the axillary contents bilaterally. Bony prominences on the upper and lower extremities
were assured for proper padding, the hips were placed into neutral extension simulating standing posture, and
10-10 drapes were used to define the surgical zone. The patient was then prepped and draped in the standard
sterile fashion
A second surgical "time out" was performed for the posterior portion of the case, along with the surgical
checklist, and the intended procedure was reviewed.
The Globus robot was initialized. We placed pelvic pins bilaterally, one to hold the globus Excelsius DRB and
the other one to hold the surveillance marker. We then placed a fiducial marker to the DRB. We obtained x-
rays at this point to make sure that are fiducial marker was over lying the spine in the area of interest both the
anterior and lateral images.we ensure that there was at least 5 fiducial markers visible on the lateral
radiograph. At this point we did an intraoperative CT scan with the Ziehm. We transferred the GT scan over to
the globus robot. We ensured that the robot was accurate by placing the chicken foot on the fiducial markers
in this check was appropriate. We planned all of the screw trajectories on the globus robot from L3-S1 . We
ensured that the L3 pedicle screw was not violating the L2-3 facet on our planning. At this point we made
bilateral Wiltse incisions. The reason for this was because of the close proximity of all the screws we felt it
would be easier to place screws if we had a larger incision instead of relying on percutaneous incisions. For
each screw that was placed, we burred our starting point, we drilled into the pedicle, we tapped, and we placed
the screw of the appropriate length all through the robotic arm. This step was done without issue for all 8
screws. We obtained Xtayg3fter screw placement, which showed concern for the L3 and L4 screws on the
Generated on 12129120 1:03 PM
42 CFR part 2 prohibits unauthorized
disclosure of these records.
FILED: KINGS COUNTY CLERK 02/14/2023 03:50 PM INDEX NO. 522897/2020
NYSCEF DOC. NO. 44 RECEIVED NYSCEF: 02/14/2023
HSS HIM MRO Ford, Patrick James
535 East 70th Street MRN: 2005536, DOB: 211911980, Sex: M
HSg NEW YORK NY'100214823 Adm: 1111312020, DIC: 11117 12020
Oo Note bv Dowdell. James E lll. MD at 1111312020 9:24 (continued)
right side as they appeared lateral. At this point we decided to get an intraoperative CT scan to ensure
appropriate screw positioning. We saw that all the screws on the left appeared to be contained in the pedicle
walls from L3-S1, forthe screws on the right L5 and S1 appearto be within the pediclewalls and L3 and L4 on
the right were indeed lateral. At this point we stimulated all the screws the remaining 6 screws from L3-S1 on
the left at Ls-S1 on the right allstimmed above 45, well above the threshold for concern. We attempted to
replace the L3 pedicl screws on the right. We were able to do