INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2012-02808
- Event Type
- Injury
- Date Received
- December 13, 2012
- Report Date
- November 13, 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
(B)(4). REVIEW OF IMAGING STUDIES FOUND AS FOLLOWS: (B)(6) 2005 LUMBAR SPINE INTERBODY DEVICE NOTED AT L5 WITH UNILATERAL PEDICLE SCREWS. ON (B)(6) 2005, MRI LUMBAR SHOWS DESICCATION L5 DISC WITH MODERATELY SIZED MIDLINE DISC HERNIATION/PROTRUSION. NO NERVE COMPRESSION OR DISPLACEMENT IS NOTED. ON (B)(6) 2005, LUMBAR CT ARTHRODESIS AT L5/S1 NOTED WITH RIGHT-SIDED APPROACH CAPSTONE AND WELL POSITIONED SCREWS RESIDUAL SPONDYLOLISTHESIS EXISTS. SCREWS ARE PRESENT ONLY ON THE RIGHT. ON (B)(6) 2012, LUMBAR MYELOGRAM/ POST MYELOGRAM CT SHOWS LEFT SIDE ENTRY TLIF WITH CAPSTONE CAGE, WHICH HAS BACKED OUT PARTIALLY. THE POSTERIOR ASPECT HAS BACKED INTO THE FORAMEN. POSSIBLE RIGHT L5 ROOT COMPRESSION IS SUSPECTED AND S1 ROOT DISPLACEMENT ON THE RIGHT IS CONFIRMED. FUSION IS CLEARLY SOLID. NO CENTRAL CANAL STENOSIS IS SEEN. ON (B)(6) 2012, AP AND LATERAL LUMBAR SHOWS PEDICLE SCREWS AT L5 AND S1 WITH MIDLINE DECOMPRESSION. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE RE PORTED 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.
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LOW BACK PAIN, LEFT HIP AND LEG PAIN, AND OCCASIONAL RIGHT BUTTOCK PAIN. AN MRI OF THE LUMBAR SPINE INDICATED "MODERATE DEGENERATIVE DISC DISEASE AT L5-S1 WITH A SMALL TO MODERATE CENTRAL DISC HERNIATION AS DESCRIBED WITH INFERIOR SUBLIGAMENTOUS EXTRUSION. GIVEN THE CAPACIOUS SIZE OF THE BONY CENTRAL SPINAL CANAL, THERE IS NO NEURAL IMPINGEMENT OR SPINAL STENOSIS. EARLY CHANGES OF INTERNAL DISC DERANGEMENT AT L4-5 WITH MINOR MIDLINE SUBLIGAMENTOUS DISC EXTRUSION BEHIND L5. ... OTHERWISE NORMAL MR SCAN OF THE LUMBAR SPINE." THE PATIENT WAS ADMITTED FOR L5-S1 DDD AND HNP, MECHANICAL BACK PAIN AND LUMBAR RADICULOPATHY. THE PATIENT UNDERWENT A MINIMALLY INVASIVE TLIF L5-S1 WITH POSTEROLATERAL ONLAY FUSION USING POSTERIOR INSTRUMENTATION, INTERBODY DEVICE, RHBMP-2/ACS AND MORSELIZED AUTOGRAFT. THE BMP WAS PLACED WITHIN THE INTERBODY PEEK SPACER AND ALSO USED IN THE POSTEROLATERAL ONLAY FUSION. THERE WERE NO NOTED COMPLICATIONS. POST-OPERATIVELY THE PATIENT HAD SIGNIFICANT DIFFICULTIES WITH PAIN MANAGEMENT. THE PREOPERATIVE LEG PAIN WAS COMPLETELY RESOLVED, HOWEVER THE PATIENT COMPLAINED OF PERSISTENT INTRACTABLE BACK PAIN. THE PATIENT WAS DISCHARGED ON POD 3. 136 DAYS POST-OP AP AND LATERAL LUMBAR SPINE X-RAYS INDICATE "INTERBODY GRAFT AT L5-S1 AND INSTRUMENTATION ON THE RIGHT SIDE AT L5-S1." THE PATIENT UNDERWENT A RIGHT L5 SELECTIVE NERVE ROOT INJECTION AND RIGHT INTERARTICULAR SACROILIAC JOINT INJECTION UNDER FLUOROSCOPIC GUIDANCE. PER THE PHYSICIAN'S NOTES, THE PATIENT "IS FOUR MONTHS STATUS POST A MINIMALLY INVASIVE L5-S1 TLIF AND HAS HAD A ROCKY POSTOPERATIVE COURSE. SHE UNFORTUNATELY CONTINUES TO HAVE WHAT APPEARS TO BE RIGHT L5 RADICULAR PAIN THAT HAS BEEN REFRACTORY TO MEDICATIONS AND THERAPY." AT 170 DAYS POST-OP, AN MRI OF THE LUMBAR SPINE INDICATED "POST OPERATIVE CHANGES ON THE RIGHT AT L5-S1 WITH A PEDICLE SCREW AND MILD RIGHT FORAMINAL COMPROMISE AT THIS LEVEL DUE TO SPONDYLOSIS. THE CANAL AND NEUROFORAMINA ARE PATENT AT ALL OTHER LEVELS." AN ADDENDUM TO THE REPORT STATES "CORRELATION IS MADE WITH A PREVIOUS MRI FROM CDI DATED (B)(4) 2005. THE DISC PROTRUSION AT L4-5 IS NO LONGER APPRECIATED. POST-OPERATIVE CHANGES ARE NEW SINCE THE STUDY FROM 2005." AT 183 DAYS POST-OP, THE PATIENT PRESENTED FOR AN OFFICE VISIT. PER THE PHYSICIAN'S NOTES, "WE SENT HER FOR A BLOCK AT ONE POINT FOR THE RIGHT LEG PAIN THINKING IT WAS L5, AND THIS SEEMED TO CONFIRM THE SOURCE OF HER PAIN. SHE IS STILL IN THE HEALING PROCESS FROM HER SURGERY." AT 192 DAYS POST-OP, THE PATIENT PRESENTED WITH BACK AND RIGHT GREATER THAN LEFT LOWER EXTREMITY PAIN. PER THE PHYSICIAN'S NOTES, "CURRENTLY SHE COMPLAINS OF APPROXIMATELY 70% LOW BACK PAIN AND 30% LEG PAIN. HER LEG PAIN IS PRIMARILY IN THE LEFT AND RIGHT FOOT AND ALONG THE POSTERIOR LATERAL ASPECT OF HER RIGHT LEG. ALL ACTIVITIES SEEM TO AGGRAVATE HER PAIN. IT IS DIFFICULT FOR HER TO IDENTIFY ANY RELIEVING FACTORS. SHE HAS NOTICED SOME MUSCLE TWITCHES AND SPASMS IN HER CLAVE BILATERALLY. SHE COMPLAINS OF MILD SUBJECTIVE WEAKNESS." AT 260 DAYS POST-OP, A CT SCAN OF THE LUMBAR SPINE INDICATED "STATUS POST POSTEROLATERAL FUSION ON THE RIGHT AT L5-S1 WITH INTERVAL DEVELOPMENT OF ENDPLATE AND VERTEBRAL BODY LYTIC CHANGES LIKELY RELATED TO BMP FUSION MATERIAL. THERE ALSO HAS BEEN BONY PROLIFERATION WITHIN THE RIGHT L5-S1 FORAMEN DEVELOPING FORAMINAL STENOSIS." AT 329 DAYS POST-OP, THE PATIENT PRESENTED WITH HARDWARE PAIN RELATED TO PRIOR INSTRUMENTATION AND LUMBAR RADICULOPATHY. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE INSTRUMENTATION, EXPLORE THE FUSION, AND EXPLORE L5 AND S1 NERVE ROOTS WITH S1 FORAMINOTOMY AND LYSIS OF ADHESIONS. PER THE OPERATIVE NOTES, "THERE WAS A SIGNIFICANT AMOUNT OF SCAR TISSUE NOTED IN BETWEEN THE PEDICLES AND MEDIALLY AS WELL. ... ONCE THE SCAR TISSUE WAS GENTLY DISSECTED AWAY, IT WAS FOUND THAT THERE WAS A BONE WHICH HAD FORMED IN BETWEEN THE L5 AND S1 PEDICLES. THIS BONE WAS REMOVED IN ORDER TO ACCESS THE INTERPEDUNCULAR SPACE. THE L5 NERVE ROOT WAS FOUND TO BE EXITING AND IT WAS GENTLY DISSECTED FREE OF SCAR TISSUE. THERE WAS FOUND TO BE A SOMEWHAT TIGHT OPENING IN THE FORAMEN." THERE WERE NO NOTED COMPLICATIONS. 360 DAYS POST-OP THE PATIENT PRESENTED FOR AN OFFICE VISIT. PER THE PHYSICIAN'S NOTES, "SHE IS NOW ONE MONTH POSTOP FOR REMOVAL OF HER LUMBAR INSTRUMENTATION. PREOPERATIVELY SHE COMPLAINED OF SHARP SHOOTING PAIN IN HER RIGHT BUTTOCK THAT WOULD TEND TO RADIATE DOWN THE RIGHT LEG. POSTOP SHE HAS DONE FAIRLY WELL. SHE FEELS AS THOUGH HER SHARP SHOOTING RIGHT BUTTOCK PAIN HAS BASICALLY RESOLVED. SHE STILL NOTES SOME LOW BACK PAIN AND SOME PAIN THAT RADIATES DOWN THE RIGHT LOWER EXTREMITY IN THE LATERAL DISTRIBUTION. OVERALL THE PROXIMAL PAIN IS SOMEWHAT RESOLVING. SHE STILL HAS SOME PERSISTENT LATERAL ANKLE DISCOMFORT." AT 2277 DAYS POST-OP, THE PATIENT PRESENTED WITH LOW BACK PAIN AND RADICULOPATHY. AN MRI OF THE LUMBAR SPINE INDICATED "POSTOPERATIVE CHANGES CONSISTENT WITH INTERBODY FUSION L5-S1. POSTERIOR DISPLACEMENT OF THE SPACER AT L5-S1 WHICH PROJECTS INTO THE RIGHT SUBARTICULAR ZONE AND RIGHT L5-S1 NEURAL FORAMEN." AT 2293 DAYS POST-OP, A CT SCAN OF THE LUMBAR SPINE, POST-MYELOGRAM, INDICATED "BLUNTING OF CONTRAST RIGHT S1 NERVE ROOT SHEATH CORRESPONDING TO LATERAL RECESS STENOSIS AND POSSIBLE RIGHT S1 IMPINGEMENT. ANNULAR BULGE AT L3-4 AND L4-5 WITHOUT MYELOGRAPHIC EVIDENCE OF SIGNIFICANT CANAL COMPROMISE OR ADDITIONAL IMPINGEMENT." AT 2317 DAYS POST-OP, THE PATIENT PRESENTED WITH ACUTE BACK PAIN. AN ELECTROMYOGRAPHY REPORT INDICATED "THERE ARE CHRONIC NEUROGENIC CHANGES, MAXIMAL AT L4-5 SEGMENTS IN BOTH LOWER EXTREMITIES. THESE CHANGES APPEAR TO BE CHRONIC IN NATURE. NO EVIDENCE OF AN ACTIVE ONGOING DENERVATION COULD BE SEEN IN THE L5 OR S1 ROOT SEGMENTS. THE NONRECORDABLE SENSORY NERVE ACTION POTENTIALS CAN BE SEEN IN PATIENTS WITH SENSORY NEUROPATHIES." AT 2334 DAYS POST-OP, THE PATIENT PRESENTED FOR AN OFFICE VISIT. THE PATIENT WAS DIAGNOSED WITH POSSIBLE S1 RADICULOPATHY. THE PATIENT UNDERWENT A RIGHT S1 NERVE ROOT INJECTION. AT 2345 DAYS POST-OP, A NOTE IN THE PATIENT'S MEDICAL RECORDS STATES "A CT MYELOGRAM ... THERE APPEARS TO BE AN INSTRUMENT AT LEVEL L5-S1 WITH AN INTERBODY DEVICE, AND THERE DOES NOT APPEAR TO BE COMPLETE OSSEOUS UNION ACROSS THE L5-S1 JUNCTION. OVERALL, I DO NOT SEE ANY SIGNIFICANT CANAL COMPROMISE AT ANY LEVEL. THERE DOES NOT APPEAR TO BE ANY SIGNIFICANT NEUROLOGIC COMPRESSION WITH THE EXCEPTION OF THE RIGHT S1 NERVE ROOT. THERE DOES APPEAR TO BE SOME SLIGHT DECREASED FILLING OF THE RIGHT S1 NERVE ROOT SLEEVE, AS WELL AS SOME MASS EFFECT ON THE NERVE ROOT THAT APPEARS TO BE FROM THE INTERBODY DEVICE. THE INTERBODY DEVICE DOES NOT APPEAR TO BE COMPLETELY SEATED PAST THE POSTERIOR CORTEX OF THE L5 OR S1 BODIES. ANOTHER NOTE STATES "MRI SCAN OF HER LUMBAR SPINE" THERE DOES APPEAR TO BE A HYPOPLASTIC DISK AT WHAT I AM GOING TO CALL S1-S2. THE FIRST MOBILE SEGMENT IS L5-S1. THERE IS AN INTERBODY DEVICE AT L5-S1. AGAIN, I FIND NO OVERALL SIGNIFICANT CANAL COMPROMISE. THERE IS IMPINGEMENT OF THE RIGHT S1 NERVE ROOT AT THE LEVEL OF THE INTERBODY DE VICE, AND THIS APPEARS TO BE DIRECTED RELATED TO THE INTERBODY DEVICE THAT IS NOT COMPLETELY SEATED WITHIN THE DISK SPACE. AT 2387 DAYS POST-OP, THE PHYSICIAN'S NOTES STATE "WITH PROVOCATIVE TESTING AND A DISKOGRAM, SHE APPARENTLY HAD 10/10 CONCORDANT PAIN AT THE L5-S1 LEVEL. SHE HAS CONTINUED TO HAVE DISCOMFORT SINCE I SAW HER LAST, AND IN FACT HAS HAD A SIGNIFICANT DECLINE OVER THE LAST 4 TO 6 WEEKS." THE PATIENT WAS SCHEDULED TO HAVE A REVISION DECOMPRESSION BILATERALLY AT L5-S1 WITH POSTERIOR LUMBAR FUSION USING BMP. AT 2396 DAYS POST-OP, THE PATIENT PRESENTED WITH LOW BACK PAIN AND BILATERAL LOWER EXTREMITY PAIN. PER THE PHYSICIAN'S NOTES "I HAVE REVIEWED THE CASE WITH ONE OF MY SENIOR PARTNERS" AND DURING THAT DISCUSSION WE FELT THAT SHE HAD SIGNIFICANT BONY OVERGROWTH, AS WELL AS LIKELY AN INFLAMMATORY COMPONENT RELATED TO USE OF BMP DURING HER INITIAL FUSION PROCEDURE WE HAD ANOTHER DISCUSSION REGARDING THE BMP TODAY, AND AT THIS POINT IN TIME, [PATIENT] WOULD LIKE TO USE HER ILIAC CREST, HER OWN BONE GRAFT, FOR THE FUSION PURPOSES. AT 2406 DAYS POST-OP, THE PATIENT UNDERWENT A REVISION LAMINECTOMY AND DECOMPRESSION OF BILATERAL S1 NERVE ROOTS AT L5-S1, REMOVAL OF THE PORTION OF THE PEEK INTERBODY DEVICE IMPINGING THE RIGHT S1 NERVE ROOT, AND POSTERIOR SPINAL FUSION L5-S1 WITH INSTRUMENTATION AND ILIAC CREST BONE GRAFT. THERE WERE NO NOTED COMPLICATIONS. AT 2424 DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "OVERALL, SHE IS DOING FAIRLY WELL" SHE CONTINUES TO HAVE LOW BACK DISCOMFORT, AS WELL AS THROBBING PAIN IN BOTH LOWER EXTREMITIES, HOWEVER. THE PAIN THAT SHE WAS HAVING PRIOR TO SURGERY HAS IMPROVED. AT 2450 DAYS POST-OP, THE PHYSICIAN'S NOTES INDICATE THAT "SHE IS HAVING BACK PAIN PRIMARILY ON THE RIGHT SIDE, AS WELL AS NUMBNESS, TINGLING, PINS AND NEEDLES INVOLVING BOTH LOWER EXTREMITIES." AT 2459 DAYS POST-OP, THE PATIENT PRESENTED WITH PERSISTENT LOWER EXTREMITY NUMBNESS, TINGLING, AND PAIN. AT 2466 DAYS POST-OP, THE PATIENT PRESENTED WITH PAIN AND PARESTHESIAS IN BILATERAL LOWER EXTREMITIES, RIGHT WORSE THAN LEFT. MOTOR NERVE CONDUCTION STUDIES INDICATED "THERE IS MILD ELECTRODIAGNOSTIC EVIDENCE OF CHRONIC, NEUROGENIC CHANGES IN TIBIALIS ANTERIOR AND EXTENSOR DIGITONUM BREVIS. THIS LIKELY REPRESENTS A MILD, CHRONIC RIGHT L5 RADICULOPATHY. CANNOT ENTIRELY EXCLUDE A PERONEAL LESION, BUT THE NORMAL PERONEAL MOTOR NERVE CONDUCTIONS MAKE THIS MUCH LESS LIKELY." AT 2499 DAYS POST-OP, THE PATIENT PRESENTED WITH PERSISTENT LOW BACK DISCOMFORT AND LOWER EXTREMITY NUMBNESS, TINGLING, AND PAIN.
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 | Required Intervention |