INFUSE BONE GRAFT

Report

Report Number: 1030489-2012-02715
Event Type: Injury
Date Received: December 10, 2012
Date of Event: January 24, 2011
Report Date: November 8, 2012
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: NEK
PMA / PMN Number: P000058
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

(B)(6). (B)(4). A REVIEW OF IMAGING STUDIES FOUND AS FOLLOWS: (B)(6) 2011 MRI LUMBAR SAGITTAL VIEWS VERIFY PREVIOUS L5/S1 TLIF WITH THE CAPSTONE SPACER PLACED THROUGH TRANS FACET RIGHT-SIDED ENTRY. POSSIBLE SCAR MAY INVOLVE TRANSITIONING S1 ROOT. SPACER POSITION IS SATISFACTORY. FUSION APPEARS SOLID. NO SIGNIFICANT HETEROTOPIC BONE IS VISUALIZED. RODS AND SCREWS AT L5 AND S1 APPEAR IN SATISFACTORY. (B)(6) 2011 MRI LUMBAR MINIMAL INTERVAL CHANGE FROM MRI OF FEBRUARY. CONSOLIDATION OF FUSION APPEARS TO HAVE ADVANCED ON THE AP VIEW, ALTHOUGH SOLID ARTHRODESIS IS STILL NOT CONFIRMED ON SAGITTAL VIEWS. (B)(6) 2008 MRI BRAIN NO SPACE OCCUPYING LESIONS, MAJOR CORTICAL ATROPHY OR MIDLINE DEVIATIONS NOTED. (B)(6) 2008 MRI CERVICAL MODERATE DEGENERATIVE CHANGES ARE NOTED FROM C2 THROUGH C6. BULGING IS NOTED AT C5/6 AND C6/7. NO EVIDENCE OF STENOSIS OR CORD COMPRESSION ON SAGITTAL VIEWS. AXIAL T2 VIEWS VERIFY NO HNP OR SIGNIFICANT CORD COMPRESSION/STENOSIS. FORAMEN APPEAR SYMMETRICAL. NO SOFT TISSUE ABNORMALITIES ARE SEEN. (B)(6) 2011 XR MYELOGRAM MULTIPLE X-RAYS VIEWS ARE OBTAINED OF LUMBAR SPINE SHOWING PEDICLE SCREWS AT L5/S1 WITH INTERBODY SPACER. MYELOGRAM DYE COLUMN APPEARS INTACT WITHOUT MAJOR ROOT SLEEVE CUT OFF OR EVIDENCE OF CANAL ENCROACHMENT. (B)(6) 2011 CT LUMBAR POST MYELOGRAM CT SHOWS PREVIOUS L5/S1 FUSION. AGAIN NOTED ARE SCREWS AND SPACER IN GOOD POSITION. ANATOMIC ALTERATION OF PERIFACET AREA ON THE RIGHT WHERE CAPSTONE WAS INTRODUCED IS NOTED. CALCIFICATION OF SCAR TISSUE IN THIS REGION IS SUSPECTED ALTHOUGH THE EXITING L5 ROOT APPEARS TO EXIT WITHOUT COMPRESSION. NO CENTRAL STENOSIS IS NOTED. LEVELS ABOVE ARE NORMAL WITHOUT DEGENERATIVE CHANGES. SCREWS MAY BE BICORTICAL LEFT S1. FUSION APPEARS SOLID. THE DEVICE WAS NOT 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR SPONDYLOSIS AND DEGENERATIVE DISK DISEASE. THE PATIENT UNDERWENT A MINIMALLY INVASIVE RIGHT L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH POSTEROLATERAL ARTHRODESIS, LAMINECTOMY, INSTRUMENTATION, AND INTERBODY CAGE PLACEMENT USING RHBMP-2/ACS, POSTERIOR INSTRUMENTATION, AND AN INTERBODY CAGE. THERE WERE NO NOTED COMPLICATIONS. 1 DAY POST-OP, X-RAYS OF THE LUMBAR SPINE INDICATED "NO RADIOGRAPHIC EVIDENCE OF HARDWARE FAILURE. L5-S1 FUSION." THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON POD 2. AT 13 DAYS POST-OP, THE PATIENT PRESENTED FOR HIS FIRST POST-OP VISIT. PER THE PHYSICIAN'S NOTES, "HIS BACK PAIN HAS IMPROVED. HIS RIGHT LEG PAIN HAS RESOLVED, HOWEVER HE HAS NEW LEFT LEG PAIN INTO THE TOP OF THE FOOT THAT IS RATED 10/10 WHEN PRESENT WHICH IS 90% OF THE TIME. THIS STARTED IN THE HOSPITAL. HE IS TAKING 1 PERCOCET EVERY 6 HOURS AND BACLOFEN. HE DENIES WEAKNESS OR INCONTINENCE." AT 36 DAYS POST-OP, THE PATIENT PRESENTED FOR A POST-OP FOLLOW UP VISIT. PER THE PHYSICIAN'S NOTES, "HE HAD LEFT PAIN THAT RESOLVED WITH MEDROL DOSEPAK. HOWEVER, HE STATES HE STARTED HAVING RIGHT LEG PAIN THAT TRAVELS DOWN THE BACK OF HIS LEG TO THE BOTTOM OF HIS FOOT AND RATED 10/10." THE PATIENT WAS ADDITIONALLY DIAGNOSED WITH C7-T1 CERVICAL SPONDYLOSIS. X-RAYS OF THE LUMBAR SPINE INDICATED "PATIENT IS STATUS POST POSTERIOR ROD AND PEDICLE SCREW FUSION AT L5-S1. THE COMPONENTS APPEAR WELL SEATED AND UNCHANGED. LATERAL ALIGNMENT IS UNCHANGED IN COMPARISON TO THE PREVIOUS EXAMINATION." AT 43 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP COMPLAINING OF RIGHT LEG PAIN. PER THE PHYSICIAN'S NOTES, "[PATIENT] CONTINUES TO HAVE UNEXPLAINED SEVERE PAIN DOWN HIS RIGHT LEG. I CANNOT SEE A PROBLEM ON HIS MRI." AN MRI OF THE LUMBAR SPINE INDICATED "L5-S1 PLIF NOTED WITH ENHANCING SCAR WITHIN THE RIGHT LATERAL RECESS BUT NO RECURRENT DISC HERNIATION IS SEEN." AT 55 DAYS POST-OP, A CT SCAN OF THE LUMBAR SPINE INDICATED "POSTERIOR FUSION AT L5-S1 WHICH IS IN GOOD ALIGNMENT, BUT THERE IS MODERATE-TO-SEVERE RIGHT FORAMINAL STENOSIS SECONDARY TO SOFT TISSUE DENSITY WHICH APPEARS TO BE SCAR MATERIAL." A LUMBAR MYELOGRAM INDICATED "NO SIGNIFICANT THECAL CANAL OR FORAMINAL STENOSIS IS SEEN. THE L5-S1 VERTEBRAL BODY LEVEL IS LIMITED DUE TO THE POSTERIOR FIXATION DEVICE." AT 57 DAYS POST-OP, THE PATIENT PRESENTED WITH RIGHT LEG PAIN. THE PATIENT WAS ASSESSED AS HAVING LUMBOSACRAL SPONDYLOSIS WITHOUT MYELOPATHY AND SPINAL STENOSIS OF THE LUMBAR REGION WITH NEUROGENIC CLAUDICATION. A REDO RIGHT L5-S1 LAMINOTOMY/FORAMINOTOMY WAS DISCUSSED. AT 58 DAYS POST-OP, THE PATIENT UNDERWENT A REDO EXPLORATION LUMBAR LAMINOTOMY L5-S1 ON THE RIGHT TO TREAT RECURRENT RIGHT L5-S1 LUMBAR STENOSIS. PER THE OPERATIVE NOTES, "THERE WAS A SIGNIFICANT AMOUNT OF SCAR TISSUE FORMED AROUND THE NERVE OUT OF BONY EDGES." THERE WERE NO NOTED COMPLICATIONS. AT 69 DAYS POST-OP, THE PATIENT PRESENTED FOR POST-OP FOLLOW UP. PER THE PHYSICIAN'S NOTES, "HE CONTINUES TO HAVE PAIN THAT GOES DOWN THE RIGHT LEG BUT IS NOW INTERMITTENT AND HE HAS BETTER MOBILITY." AT 113 DAYS POST-OP, THE PATIENT PRESENTED FOR POST-OP FOLLOW UP. PER THE PHYSICIAN'S NOTES, "HE CONTINUES TO HAVE POSITIONAL HEADACHES. HE DOES NOT HAVE CONSISTENT HEADACHES WHEN HE STANDS. HIS HEADACHES ARE IMPROVED WHEN HE LAYS BACK. HE IS CURRENTLY TAKING BC POWDERS AND FIORINAL FOR HIS HEADACHES. HE CURRENTLY COMPLAINS OF NO LEG PAIN IF HE SITS. HE STARTS TO HAVE LEG PAIN IF HE MOVES OR GETS ACTIVE. HE SAYS THIS IS BETTER THAN IT WAS BEFORE THE LAST SURGERY." AT 328 DAYS POST-OP, THE PATIENT PRESENTED WITH LOW BACK PAIN AND NECK PAIN. PER THE PHYSICIAN'S NOTES, "PRESENTS WITH C/O PAIN BASE OF THE NECK ON THE LEFT SIDE. THE PAIN RADIATES TO THE THIRD AND FOURTH DIGITS ON THE LEFT. THE INCITING EVEN WAS ACCIDENT AT WORK WITH SOMETHING FALLING ON HIS HEAD. THERE IS ALSO TINGLING/NUMBNESS DOWN TO BOTH ARMS, IN FOURTH AND FIFTH DIGITS. PATIENT ALSO C/O WEAKNESS IN GRIP AND [PATIENT] CONTINUES TO COMPLAIN OF PAIN IN THE SUPERIOR SACRAL AREA THAT TRAVELS INTO THE RIGHT LEG INTO THE THREE MIDDLE TOES." A SPINAL CORD STIMULATOR TRIAL WAS RECOMMENDED, AS WELL AS ACDF C6-T1. X-RAYS OF THE LUMBAR SPINE INDICATED "L5-S1 POSTERIOR FUSION SURGERY WITH BONE SCREWS AND POSTERIOR RODS. DISC SPACERS ALSO PRESENT. DISC ALIGNMENT IS SATISFACTORY." AT 448 DAYS POST-OP, THE PATIENT UNDERWENT RIGHT L5 AND RIGHT S1 TRANSFORAMINAL EPIDURAL STEROID INJECTIONS. THERE WERE NO NOTED COMPLICATIONS. AT 469 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. AT 490 DAYS POST-OP, THE PATIENT PRESENTED WITH LOW BACK PAIN WITH RADICULAR SYMPTOMS DOWN THE RIGHT, GREATER THAN LEFT, LOWER EXTREMITY. AT 499 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "HE HAD A SPINAL CORD STIMULATOR TRIAL YESTERDAY AND UNFORTUNATELY, HE HAS HAD NO GOOD COVERAGE FROM THE TRIAL AND HAS HAD SOME RADIATION INTO HIS RIBS AND STOMACH REGION FROM THE TRIAL. HE RELATES HAVING NO COVERAGE FROM THE BACK OR LOWER EXTREMITY PAIN. THE PATIENT HAS HEADACHES AND IS THOUGH T TO HAVE CHRONIC CSF LEAK, WHICH SEEMS TO BE SPINAL WHEN HE LIES DOWN." AT 513 DAYS POST-OP, PHYSICIAN'S NOTES STATE "[PATIENT] WAS GIVEN A SPINAL CORD STIMULATOR TRIAL FOR MANAGEMENT OF THE CHRONIC AND INTRACTABLE PAIN IN THE RIGHT LOWER EXTREMITY. SUBSEQUENTLY, THE SPINAL CORD STIMULATOR LEAD WAS PLACED... DURING THE PROCEDURE, THE PATIENT WAS FOUND TO HAVE SPINAL CORD FLUID IN THE EPIDURAL SPACE, THOUGHT TO BE CONSISTENT WITH A CHRONIC CSF LEAK. THE TRIAL LEAD WAS REMOVED..." AT 519 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "[PATIENT] RECENTLY HAD A SPINAL CORD STIMULATOR TRIAL IN THE THORACIC REGION. UNFORTUNATELY, THE TRIAL WAS VERY DIFFICULTY. HE HAD A SIGNIFICANT AMOUNT OF SCAR TISSUE. [PHYSICIAN] WAS ONLY ABLE TO GET ONE LEAD IN AND IT GAVE HIM SIGNIFICANT ABDOMINAL SYMPTOMS. [PHYSICIAN] WAS ALSO GETTING CSF DURING THE TRIAL. AFTER THE TRIAL, HE HAD SOME HEADACHES WHICH ARE NOW RESOLVING. HIS TRIAL WAS (B)(6) 2012. HE DOES HAVE SOME POSITIONAL HEADACHES, BUT THESE SEEM TO BE RESOLVING. HE NOW COMPLAINS OF PAIN IN TO HIS RIGHT GROIN OVER THE LAST 3 MONTHS." AT 535 DAYS POST-OP, AN MRI OF THE LUMBAR SPINE INDICATED "L5-S1 PRIOR RIGHT HEMILAMINECTOMY IS NOTED WITH EPIDURAL FIBROSIS BUT NO RECURRENT DISC HERNIATION. L4-5 PRIOR PARTIAL RIGHT HEMILAMINECTOMY WITHOUT RECURRENT DISC HERNIATION. L5-S1 PLIF IS SEEN WITHOUT PSEUDOARTHROSIS." AT 538 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP WITH BACK PAIN. PER THE PHYSICIAN'S NOTES, "[PATIENT] CONTINUES TO HAVE CHRONIC PAIN WHICH IS UNEXPLAINED FROM HIS MRI."

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	M111053AAI

Patients

Seq	Age	Sex	Outcome	Treatment
1	00043 YR		Required Intervention