INFUSE BONE GRAFT

Report

Report Number: 1030489-2012-02117
Event Type: Injury
Date Received: November 13, 2012
Report Date: September 5, 2017
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: NEK
PMA / PMN Number: P000058
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

(B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

Additional Manufacturer Narrative · 1

(B)(6). (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L5-S1 USING RHBMP-2/ACS WHICH WAS PLACED ON OVER THE TRANSVERSE PROCESS OUTSIDE A CAGE. POST-OP PERIOD WAS MARKED WITH A SEVERE ONSET OF PAIN IN HIS LOWER BACK, WITH ASSOCIATED LEG NUMBNESS AND WEAKNESS. THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE PAIN. THE PATIENT CONTINUED TO EXPERIENCE SEVERE AND CHRONIC LOWER BACK AND LEG PAIN WITH RADICULOPATHY INTO HIS LOWER EXTREMITIES. REPORTEDLY, THE PATIENT COULD NOT STAND, SIT OR WALK FOR ANY LENGTH OF TIME AND REQUIRED CANE TO ASSIST WITH AMBULATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON: (B)(6) 2011, THE PATIENT UNDERWENT PLIF AT L5-S1 USING BMP AND A PEEK CAGE. THE BMP WAS ALSO PLACED OVER THE POSTEROLATERAL PROCESSES. THE PATIENT UNDERWENT FOLLOWING PROCEDURES; POSTERIOR APPROACH TO LUMBOSACRAL SPINE. BILATERAL L5-S1 LAMINECTOMY. GILL PROCEDURE. FACETECTOMY. FORAMINOTOMIES. TOTAL DISKECTOMY. L5-S1 PEDICLE SCREW FIXATION. L5-S1 INTERBODY GRAFTING USING LYNX 13-MM HIGH POSTERIOR LUMBAR INTERBODY FUSION SPACER. PEDICLE SCREW FIXATION USING DEPUY EXPEDIUM 7.5 X 50-MM SCREWS AT L5 AND 7.5 X 40-MM SCREWS AT S1. CORRECTION OF DEFORMITY WITH DISTRACTION, FOLLOWED BY COMPRESSION ON THE INTERBODY GRAFT. REDUCTION WITH PLACEMENT OF THE SCREW ROD CONSTRUCT. AUTOGRAFT-ALLOGRAFT. ARTHRODESIS. USE OF BONE MORPHOGENIC PROTEIN. PLACEMENT OF GRAVITATIONAL PLATELET SEPARATION. INTRAOPERATIVE MONITORING. PER OP NOTES, ¿..THE JUNCTION AT L5 WAS IDENTIFIED FIRST . THE 3-CUTTING BUT WAS THEN USED TO MARK THE ENTRY POINT. A PEDICLE FINDER WAS THEN USED TO SOUND PEDICLE AT 50 MM. THE HOLES WERE PROBED. THERE WAS NO EVIDENCE OF STIMULATION. AFTER STIMULATING THE HOLE, THE HOLES WERE TAPPED, AND A 7.5 X 50-MM SCREW WAS PLACED. THE SAME THING WAS DONE ON THE CONTRALATERAL SIDE AT L5 UNDER FLUOROSCOPIC GUIDANCE. THE SCREWS WERE STIMULATED WITHOUT ANY EVIDENCE OF NERVE ROOT STIMULATION. AT S1, A SIMILAR PROCESS WAS PERFORMED. THE PEDICLES WERE SOUNDED TO 40 MM. THE PEDICLES WERE PROBED, TAPED AND STIMULATED. THEN, 7.5 X 40-MM SCREWS WERE PLACED BILATERALLY AT S1. THE SCREWS WERE STIMULATED WITHOUT ANY ABNORMAL STIMULATION. ON THE LEFT-HAND SIDE, A ROD WAS PLACED AND DISTRACTED TO FURTHER OPEN THE DISK SPACE.. A 13-MM PEEK SPACER WAS THEN PACKED WITH BMP AND PLACED IN THE DISK SPACE, AND COUNTERSUNK. THERE WAS NO EVIDENCE OF NERVE ROOT STIMULATION DURING THIS PROCESS. THE ROD UNDER DISTRACTION WAS LOOSE AND THEN COMPRESSED. THE RIGHT-SIDED ROD WAS PLACED AND COMPRESSED. X-RAY WAS USED TO DEMONSTRATE GOOD SAGITTAL BALANCE, GOOD POSITION OF THE SCREWS AND RODS, INTERBODY GRAFT AT THE APPROPRIATE LEVEL..¿ UNKNOWN DATE, POST SURGERY, , THE IMAGING DEMONSTRATED A RETROPULSED INTERBODY GRAFT (CAGE MIGRATION) AT L5-S1. ON (B)(6) 2011, THE PATIENT PRESENTED WITH IMAGING REPORT DEMONSTRATING A RETROPULSED INTERBODY GRAFT (CAGE MIGRATION) AT L5-S1. THE PATIENT COMPLAINED OF LOW BACK AND BILATERAL LEG PAIN AND UNDERWENT A REVISION SURGERY AND FOLLOWING PROCEDURES WERE PERFORMED: REVISION LAMINECTOMY L5-S1. REVISION BILATERAL FORAMINOTOMIES L5-S1. INCREASED LEVEL OF DIFFICULTY GREATER THAN 50% SECONDARY TO A BIT OF SCARRING FROM PREVIOUS SURGERY. DURING THE PROCEDURE, ¿ .. THE SEQUENTIAL ALLOGRAFT BONE TUBES WERE THEN USED TO FILL THE GRAFT UNDER DIRECT FLUOROSCOPIC OBSERVATION. ONCE THE EXPANDABLE SPINEOLOGY GRAFT WAS FULLY EXPANDED, FILLING THE SPACE, THE GUIDE TUBES WERE REMOVED. AP AND LATERAL X-RAY WAS OBTAINED, SHOWING GOOD POSITIONING OF THE GRAFT AT THE APPROPRIATE LEVEL, FILLING THE DISK SPACE AND BONE VOID FROM PRIOR EROSION OF THE VERTEBRAL BODY. THE RODS WERE THEN REPLACED AND FINAL TIGHTENED. ..¿ ON (B)(6) 2011, THE PATIENT UNDERWENT CT OF LUMBAR SPINE POST SURGERY. ON (B)(6) 2011, THE PATIENT UNDERWENT MRI OF LUMBAR SPINE. ON (B)(6) 2011, THE PATIENT UNDERWENT MRI OF CERVICAL SPINE DUE TO NECK PAIN AND NUMBNESS IN UPPER EXTREMITY. IMPRESSION ; MINOR CERVICAL SPINE DISC DEGENERATIVE CHANGES. ON (B)(6) 2011, THE PATIENT UNDERWENT LUMBAR SPINE MRI DUE TO SEVERE BACK PAIN. CONCLUSION: PRESENCE OF EDEMA WITHIN THE SOFT TISSUES POSTERIOR TO THIS LEVEL. ON (B)(6) 2011, THE PATIENT PRESENTED FOR CT OF THE LUMBAR SPINE WITHOUT CONTRAST WHICH SHOWED LAMINECTOMY AT L4 VERTEBRAL BODY LEVEL WITH ANTERIOR DISK GRAFT AT L5-S1 INTERVERTEBRAL DISK SPACE LEVEL AND POSTERIOR SPINAL FUSION USING PEDICULAR SCREWS. SCREWS ARE INTACT. THE X-RAYS OF THE LUMBAR SPINE WAS ALSO PERFORMED. ON (B)(6) 2011, THE PATIENT UNDERWENT LUMBAR SPINE MRI. IMPRESSION: ¿ THERE APPEARED TO BE A RIGHT PARACENTRAL/FORAMINAL DISC PROTRUSION OF RESIDUAL DISC MATERIAL AT L5-S1 ENCROACHING UPON THE EXITING RIGHT L5 NERVE ROOT AND MINIMALLY ENCROACHING UPON THE DESCENDING RIGHT S1 NERVE ROOT. THERE WAS PROMINENT SCAR TISSUE SEEN WITHIN THE RIGHT LATERAL ASPECT OF THE SPINAL CANAL AT THE OPERATIVE SITE, SURROUNDING THE DESCENDING RIGHT S1 NERVE ROOT, ENCROACHING UPON THE EXITING RIGHT L5 NERVE ROOT WITHIN THE NEURAL FORAMEN. NO SIGNIFICANT SPINAL CANAL OR FORAMINAL STENOSIS WAS NOTED AT THIS LEVEL. MILD FORAMINAL STENOSIS NOTED AT L4-5 RELATED TO DEGENERATIVE CHANGES ¿ ON (B)(6) 2011, THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. IMPRESSION: RIGHT PARACENTRAL HERNIATION MEASURING 7 MM AP LIKELY PRESSING ON THE RIGHT DESCENDING S1 NERVE ROOT. IT MAY BE TOUCHING THE RIGHT EXITING L5 NERVE ROOT AS WELL. DETAILS ARE SOMEWHAT LIMITED DUE TO ADJACENT METALLIC ARTIFACTS FROM PEDICULAR SCREWS. THERE IS NO SPINAL STENOSIS AT ANY LEVEL. THE REMAINING DISC SPACES AND VERTEBRAL HEIGHTS ARE NORMAL. ON (B)(6) 2011, THE PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. PROMINENT SCAR TISSUE WAS SEEN ALONG THE RIGHT LATERAL ASPECT OF THE SPINAL CANAL. ON (B)(6) 2012, THE PATIENT PRESENTED DUE TO RECENT FALL AND BACK PAIN AND UNDERWENT X-RAYS OF LUMBAR SPINE. IMPRESSION; NO EVIDENCE OF ACUTE FRACTURE. NO ABNORMAL MOTION WITH FLEXION AND EXTENSION VIEWS. ON (B)(6) 2012, THE PATIENT PRESENTED DUE TO PAIN AND UNDERWENT X-RAYS OF LUMBAR SPINE. IMPRESSION; THERE IS DEGENERATIVE DISK DISEASE IN THE LOWER LUMBAR SPINE. ON (B)(6) 2012, PATIENT UNDERWENT ANOTHER MRI DUE TO WEAKNESS, BILATERAL PAIN AT LOWER EXTREMITIES, WHICH SHOWED MATERIAL WITHIN THE DISC SPACE AT L5-S1 PROJECTED POSTERIORLY TOWARDS THE RIGHT EPIDURAL SPACE WHERE IT APPROACHED BUT NOT CLEARLY IMPINGED UPON THE RIGHT L5 NERVE ROOT. THIS NERVE ROOT IMPINGEMENT MAKES ANOTHER REVISION PARTICULARLY RISKY ON (B)(6) 2012, THE PATIENT UNDERWENT LUMBOSACRAL SPINE X-RAYS DUE TO PAIN AND NUMBNESS. ON (B)(6) 2012, THE PATIENT UNDERWENT X-RAYS OF THE LUMBAR SPINE-5 VIEWS. IMPRESSION: PRIOR FUSION AND LAMINECTOMY AT L5-S1. NO SIGNIFICANT CHANGE SINCE THE PREVIOUS STUDY. NO EVIDENCE FOR FRACTURE OR ACUTE OSSEOUS ABNORMALITY. ON (B)(6) 2012, PATIENT HAD A CT SCAN OF LUMBAR SPINE , WHICH SHOWED ¿THE PROSTHETIC DISC MATERIAL AT L5-S1 HAD ERODED INTO THE INFERIOR ENDPLATE OF L5 WITH APPROXIMATELY 50% OF THE INFERIOR HALF OF THE L5 VERTEBRAL BODY HAVING ERODED. THERE MAY BE A COMPONENT OF NEURAL FORAMINAL NARROWING AT L5-S1 DUE TO HYPERTROPHIC BONE, HOWEVER THERE IS NO CONTRAST MATERIAL EXTENDING INTO THE NEURAL FORAMINA TO FURTHER EVALUATE THIS REGION.¿ ON (B)(6) 2013, PATIENT UNDERWENT ANOTHER CT SCAN , WHICH SHOWED ¿LACK OF FUSION AT L5-S1 WITH LOSS OR ABSENCE OF BONE INVOLVING THE INFERIOR ASPECT OF L5. PROMINENT DENSITY IN THE RIGHT ANTERIOR EPIDURAL SPACE POSTERIOR TO L5 AND L5-S1 WHICH MAY REPRESENT UNFUSED GRAFT MATERIAL. THIS COULD COMPRESS THE EXITING L5 NERVE ROOT.¿ ON (B)(6) 2014, PATIENT WAS IMPLANTED WITH A SPINAL CORD STIMULATOR. ON (B)(6) 2014, THE PATIENT PRESENTED FOR THORACIC AND LUMBAR SPINE MYELOGRAM DUE TO LOW BACK PAIN AND LEG NUMBNESS. IMPRESSION: NO CENTRAL STENOSIS IN THE THORACIC SPINE. THE X RAYS OF THE THORACIC INDICATED MILD TO EARLY MODERATE DEGENERATIVE DISC DISEASE IN THE THORACIC SPINE THE X-RAYS OF THE LUMBAR SPINE SHOWED MILD DEGENERATIVE CHANGES. THE CT OF THE THORACIC MYELOGRAM SHOWED MILD MULTILEVEL DEGENERATIVE DISC DISEASE INCLUDING VERTEBRAL ENDPLATE SPONDYLOSIS ANTERIORLY. THE CT SCAN OF THE LUMBAR SPINE PERFORMED WHICH SHOWED ALIGNMENT IS NEARLY NORMAL WITH 3MM OR LESS SPONDYLOLISTHESIS AT L5-S1. ON (B)(6) 2015, THE PATIENT HAD A LUMBAR MYELOGRAM/CT SCAN. IT SHOWED MIGRATION OF DISC FUSION MATERIAL VERSUS BONE FRAGMENTS POSTEROLATERAL INTO THE RIGHT NEUROFORAMINAL CAUSING SEVERE RIGHT NEUROFORAMINAL STENOSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFUSE BONE GRAFT	FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET	NEK	MEDTRONIC SOFAMOR DANEK USA, INC	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Other\| R