INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-04258
- Event Type
- Injury
- Date Received
- November 6, 2014
- Report Date
- October 9, 2014
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
Narratives
(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.
ON(B)(6) 2004, THE PATIENT UNDERWENT HEMILAMINECTOMY WITH MEDIAL FACETECTOMY AND FORAMINOTOMY C6-7,LEFT AND RIGHT, SEGMENTAL INSTRUMENTA TION C3-C7, ARTHRODESIS C3-C7 AND TONG APPLICATION FOR SURGERY USING BMP ALLOGRAFT AND APPROPRIATE SIZED ROD TO TREAT PSEUDOARTHROSIS, DDD AND SPINAL STENOSIS WITH MYELOPATHY. ANOTHER REPORT ALSO DATED (B)(6) 2004 STATED THE OPERATIVE PROCEDURE WAS THE REMOVAL OF THE ANTERIOR PLATE, EXPLORATION OF FUSION MASS C4-C7, REDO PSEUDOARTHROSIS WITH DISCECTOMY AND DECOMPRESSION AND BILATERAL FORM INATOMY C4-C7, ANTERIOR CERVICAL DISCECTOMY, PARTIAL VERTEBRECTOMY, AND BILATERAL FORAMINOTOMY C3-C4. ANTERIOR CERVICAL FUSION C3-C7, ALLOGRAFT STRUCTURAL WITH BMP C3-C7 AND ANTERIOR CERVICAL PLATE ON (B)(6) 2005 PT HAD A CT OF THE THORACIC AND LUMBAR SPINE. THERE WERE NO PREVIOUS STUDIES FOR COMPARISON. FINDINGS FOR THE THORACIC SPINE STATED THERE IS NORMAL ALIGNMENT OF THE THORACIC SPINE, AND THE DISK SPACES PLUS VERTEBRAL BODIES ARE WELL MAINTAINED. THERE IS NO EVIDENCE OF A DISK HERNIATION, AND NO SPINAL CANAL OR NEURAL FORAMINAL STENOSIS. INCIDENTALLY NOTED IS A BONE ISLAND IN THE ANTERIOR BODY OF T10. FOR THE CT LUMBAR FINDINGS IT WAS REPORTED A SOLID POSTEROLATERAL BONY FUSION EXTENDING FROM L5-S1 THROUGH L2-3, IN ADDITION TO MULTILEVEL LAMINECTOMIES. AT L1-2, SEVERE, CHRONIC DEGENERATIVE DISK DISEASE WITH LISTHESIS POSTERIORLY AND TOWARDS THE RIGHT OF L1 ON L2. ON (B)(6) 2006, PT UNDERWENT LUMBAR EPIDURAL STEROID INJECTION. ON (B)(6) 2006, PT UNDERWENT LUMBAR MEDIAL BRANCH RHIZOTOMY. ON (B)(6) 2006, PT HAD A CT OF THE LUMBAR SPINE WITH FINDINGS STATING NO SIGNIFICANT CHANGES FROM PREVIOUS SCAN ON (B)(6) 2005, ON (B)(6) 2006, PT. UNDERWENT POSTERIOR ARTHRODESIS L1-L2 AND POSTERIOR NON-SEGMENTAL INSTRUMENTATION L1-L2 FOR DDD OF L1- L2. FINDINGS: THE PATIENT HAD AN EXTREMELY DEGENERATIVE DISK WITH COLLAPSE, RETROLISTHCSIS AND LATERALISTHESIS AT LI-2. ON (B)(6) 2008, PT UNDERWENT RETROPERITONEAL APPROACH WITH PARTIAL CORPECTOMY OF L2, ANTERIOR INSTRUMENTATION LINKED TO INTERBODY DEVICE AND RHBMP-2 ALLOGRAFT TO REPAIR A NONUNION AND HARDWARE FAILURE OF L1-L2. HEMOSTASIS WAS EXCELLENT. SURGEON DR. JOHN (B)(6) ON (B)(6) 2010, A MRI STUDY OF THE THORACIC SPINE WAS DONE DUE TO BACK PAIN AND RADICULOPATHY. FINDINGS REPORTED: APPEARS TO BE SOLID POSTERO LATERAL FUSIONS FROM L2 TO S1. AT L1-2, THERE IS A RETROLISTHESIS, AS WELL AS CHANGES OF DEGENERATIVE DISC DISEASE WITH DISC SPACE NARROWING. THERE ARE NOW POSTOPERATIVE CHANGES OF INSTRUMENTATION WITH BILATERAL PEDICLE SCREWS AT L1-2 WITH DEGENERATIVE RETROLISTHESIS. THE PEDICLE SCREW ON THE LEFT AT L2 TRAVERSES THE LEFT LATERAL RECESS AND THE PEDICLE SCREWS AT L1 ARE ON THE LATERAL ASPECT OF THE PEDICLES ENTERING THE L1 VERTEBRAL BODY. ON (B)(6) 2011, THE PATIENT PRESENTED WITH THORACIC PAIN. A THORACIC SPINE MRI SCAN WITHOUT CONTRAST AND A LUMBAR SPINE MRI SCAN WITHOUT AND WITH CONTRAST WAS ORDERED. FINDINGS REPORTED PARTIALLY VISIBLE C3-C7 FUSION WITH BONE GRAFT AND HARDWARE, UNCHANGED. THORACIC DISC BULGING AND FACET JOINT OSTEOARTHRITIS, WITHOUT STENOSIS, UNCHANGED SINCE THE PRIOR STUDY. T12-L1 DISC COLLAPSE AND RETROLISTHESIS, WITH SURROUNDING BONY STRESS REACTION, NOT SIGNIFICANTLY CHANGED. ARTIFACT FROM THE RIGHT L1 PEDICLE SCREW OVERLAPS THE T12-LL DISC SPACE, AND IT'S POSSIBLE THAT THE SCREW CROSSES THE ENDPLATE. SOLID-APPEARING L1-2 FUSION WITH BONE GRAFT AND HARDWARE. SINCE THE 2008 STUDY, THE LEFT PEDICLE SCREWS HAVE BEEN REMOVED, AND THE FUSION HAS BEEN SUPPLEMENTED WITH LEFT LATERAL PLATE AND SCREWS, INTERBODY SPACER, AND BONE GRAFT. NO RESIDUAL STENOSIS. SOLID L2-S1 FUSION WITH POSTERIOR ELEMENT BONE GRAFT AND L3-4 INTERBODY BONE GRAFT, UNCHANGED. WIDE L3 LAMINECTOMY AND L3-4 LAMINOTOMY, UNCHANGED. SHALLOW SCOLIOSIS CONVEX RIGHT AT L1-2 AND LEFT AT L3-4, UN CHANGED. ON (B)(6) 2011, PT UNDERWENT POSTERIOR LUMBAR FUSION T12-L1, POSTERIOR FUSION T11-L2, REINSERTION OF INSTRUMENTATION T11-L3, POSTERIOR SMITH PETERSON OSTEOTOMY AND RHBMP-2 ALLOGRAFT TO TREAT LUMBAR POSTLAMINECTOMY SYNDROME, THORACOLUMBAR SCOLIOSIS AND LUMBOSACRAL SPONDYLOSIS. NO COMPLICATIONS. SURGEON DR. (B)(6) ON (B)(6) 2012, PT SAW DR. WHO DETERMINED PT'S BACK PAIN TO BE RELATED TO CAR ACCIDENT. HE STATES ¿THIS IS MECHANICAL PAIN, SHE DOES NOT HAVE MYELOPATHY.¿ ON (B)(6) 2012, THE PATIENT PRESENTED WITH LOW BACK PAIN RADIATING TO THE RIGHT LOWER EXTREMITY. NECK PAIN RADIATING TO THE SHOULDERS LEFT GREATER THAN RIGHT. MID BACK PAIN. RADICULOPATHY. PER THE MEDICAL RECORDS, LUMBAR, THORACIC AND CERVICAL MYELOGRAM WAS DONE, IMPRESSION OF MYELOGRAM: STATUS POST DLIF <(>&<)>OM THE LEFT AT L1-2, SOLIDLY OSSIFIED, POSTERIOR ELEMENT BONE GRAFT FUSION <(>&<)> FROM AT LEAST T12 TO THE SACRUM, PROBABLY SOLIDLY OSSIFIED. STATUS POST LAMINECTOMY AT L2-3 AND L3-4. BILATERAL PEDICLE SCREW DEVICE SPANNING L2 TO T10, HARDWARE INTACT. STATUS POST ANTERIOR CERVICAL FUSION AT THE LEVELS C3-4 TO C6-7 INCLUSIVE, SOLIDLY OSSIFIED. ANTERIOR FIXATION PLATE SPANNING C3 TO C7, INTACT. BILATERAL LATERAL MASS PLATES AND SCREWS SPANNING C3 TO C7, INTACT. NO SIGNIFICANT EXTRADURAL DEFECT OVER THE LUMBAR SEGMENT. NO SIGNIFICANT EXTRADURAL DEFECT OVER THE THORACIC SEGMENT. MINIMAL DEGENERATIVE SUBLUXATION C2-3, UNCHANGED FROM STUDIES DATING TO 2004. NO SIGNIFICANT EXTRADURAL DEFECT OVER THE CERVICAL SEGMENT. ON (B)(6) 2012, PT RETURNED FOR BACK PAIN. DR. COMMENTS PER CT THE HARDWARE IS IN GOOD POSITION AND THE FUSION IS HEALING NICELY. PT. TREATED WITH BLOCK AT UPPER HARDWARE REGION ON (B)(6) 2012 PT MET WITH DR. (B)(6) HE STATES ¿THE HARDWARE BLOCK IN THE LOWER DID NOT GIVE HER ANY RELIEF, BUT THE FACET BLOCKS ABOVE HER FUSION AT T0-70, TO-10, AND TI0-TIF DID GIVE HER SOME PRETTY SIGNIFICANT RELIEF. THE CT MYELOGRAM OF THE LUMBER SPINE SHOWS FUSION ALL THE WAY FROM T12 TO S1 WITH DECOMPRESSION OF THE SPINAL CANAL, HARDWARE IS IN GOOD POSITION. NO FRACTURES, NO LOOSENING, AND RESTORATION OF HER LUMBAR LORDOSIS. FROM T10 TO L2, THE SCREWS ARE IN GOOD POSITION. THE L 1I-L2 DLIF IS HEELED, AND THE POSTERIOR FUSION IS HEELED ALL THE WAY UP LO T11. THERE IS QUESTION OF WHETHER THE FUSION IS COMPLETELY HEALED AT T10.TII, AND THERE ARE SOME LUCENCIES AROUND THE SCREWS. ON (B)(6) 2012, MET WITH DR. (B)(6) FOR C/O MUSCLE ACHES, MUSCLE WEAKNESS, ARTHRALGIAS/JOINT PAIN, BACK PAIN, AND SWELLING IN THE EXTREMITIES. DOCTOR STATED ¿WE WILL AWAIT RECORDS FROM CSC, BUT CONSIDER T78/89/910 RHIZO AT F/U. CONSIDER TRIGGER POINTS AT F/U. ON (B)(6) 2012, PT HAD A RIGHT T78/89/910 RHIZO FOR SPONDYLOSIS. ON (B)(6) 2012, PT UNDERWENT RIGHT T7-8, T8-9, T9-10 RADIOFREQUENCY ABLATION OF MEDIAL BRANCH NERVES WITH ANESTHESIA FOR SPONDYLOSIS. ON (B)(6) 2012, PT MET WITH DR. (B)(6) WHO PERFORMED A RIGHT C23 FACET BLOCK WHERE SHE HAS ARTHRITIS ABOVE HER FUSION AND LEFT T67/78 ESI WHERE THERE IS DDD BECAUSE HE STATED ¿SHE IS STILL NEEDING A LOT OF PAIN MEDS AND SHE'S NOT A SURGICAL CANDIDATE.¿ ON (B)(6) 2012, PT UNDERWENT RIGHT C2-3 FACET JOINT INJECTION FOR SPONDYLOSIS. ON (B)(6) 2012, PT UNDERWENT LEFT T6-7 AND T7-6 TRANSFORAMINAL EPIDURAL STEROID INJECTION FOR RADICULOPATHY ON (B)(6) 2012, AND (B)(6) 2013, PT MET WITH DR. (B)(6) WHO PERFORMED TRIGGER POINT INJECTIONS TO BILATERAL TRAPEZIUS, SPLENIUS CERVICUS, AND LEVATOR SCAPULA FOR MYOFASCIAL PAIN SYNDROME. ON (B)(6) 2013, PT UNDERWENT RIGHT T7-6, T8-9 AND T9-10 RADIOFREQUENCY ABLATION OF MEDIAL BRANCH NERVES WITH ANESTHESIA FOR SPONDYLOSIS. ON (B)(6) 2013, THE PATIENT PRESENTED WITH C/O RIGHT SIDED THORACIC PAIN S/P MULTIPLE PREVIOUS FUSION PROCEDURES WITH INSTRUMENTATION X SEVERAL YEARS. PATIENT HAS FAILED CONSERVATIVE TREATMENT INCLUDED BUT NOT LIMITED TO ORAL ANALGESICS, EPIDURAL STEROID INJECTIONS, FACET INJECTIONS AND RHIZOTOMIES, AND HARDWARE INJECTIONS. TREATMENT PLAN: PLAN HARDWARE REMOVAL WITH EXPLORATION/AUGMENTATION OF FUSION. ON (B)(6) 2013, THE PATIENT UNDERWENT HARDWARE REMOVAL AT T10 TO 12. EXPLORATION OF FUSION, T10 TO L2. PSEUDOARTHROSIS TAKEDOWN AT T10-11. POSTERIOR THORACIC FUSION AT T1.0-11. ALLOGRAFT (CONDUCT, EXEMPLIFY) TO TREAT PSEUDOARTHROSIS AT T10-11, SYMPTOMATIC POSTERIOR SPINAL HARDWARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713756 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | POSTERIOR INSTRUMENTATION |