INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2012-02413
- Event Type
- Injury
- Date Received
- November 20, 2012
- Report Date
- February 16, 2018
- 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
(B)(4).
(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 INFORMATION: PT IDENTIFIER, ADVERSE EVENT AND/OR PRODUCT PROBLEM, DESCRIBE EVENT OR PROBLEM, (B)(4). 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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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.
IT WAS REPORTED THAT ON, (B)(6) 2009, THE PATIENT UNDERWENT SECOND POSTERIOR LUMBAR INTERBODY FUSION SURGERY INVOLVING RHBMP-2/ACS, FROM VERTEBRAE L3-4. THE RHBMP-2 COLLAGEN SPONGE WAS PLACED OUTSIDE A CAGE IN LATERAL GUTTERS. REPORTEDLY, DESPITE ALL THE SURGERIES, THE PATIENT "CONTINUES TO EXPERIENCE SEVERE AND CHRONIC LOW BACK PAIN WITH BURNING PAIN INTO HIS RIGHT BUTTOCK AND LEGS. PATIENT ALSO SUFFERS FROM NEUROGENIC BLADDER." ON (B)(6) 2009: THE PATIENT PRESENTED WITH DEGENERATIVE DISC DISEASE WITH INSTABILITY AND RADICULITIS L3-4. THE PATIENT UNDERWENT BILATERAL LAMINECTOMY AND FASCIECTOMY FOR NERVE ROOT DECOMPRESSION WITH COMPLETE DISCECTOMY, MICRO-SURGICAL TECHNIQUE WITH POSTERIOR INTER-BODY FUSION UTILIZING PEEK FUSION CAGES WITH RHBMP-2 ALLOGRAFT AND PEDICLE SCREW INSTRUMENTATION L3-4, WITH POSTEROLATERAL/INTER-TRANSVERSE PROCESS FUSION WITH LOCAL BONE AUTOGRAFT, RHBMP-2 ALLOGRAFT, ALLOGRAFT AND TRICALCIUM PHOSPHATE ALLOGRAFT. AS PER-OP NOTES, " THE PEEK CAGES WERE SELECTED OF APPROPRIATE SIZE, FILLED LOOSELY WITH RHBMP-2 ALLOGRAFT AND GENTLY IMPACTED INTO THE INTER-SPACE BILATERALLY. ADDITIONAL LOCAL BONE AUTOGRAFT AND RHBMP-2 WAS PLACED IN THE ANTERIOR INTER-BODY SPACE PRIOR TO PLACING THE CAGES. AFTER PLACING THE PEDICLE SCREWS AT L3 AND L4, THE GRAFT WAS PLACED USING RHBMP-2 OVER THE TRANSVERSE PROCESSES FOLLOWED BY ALLOGRAFT, FOLLOWED BY LOCAL AUTOGRAFT, AND FINALLY TRICALCIUM PHOSPHATE STRIPS. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2010: THE PATIENT UNDERWENT MRI OF LUMBAR SPINE WITH AND WITHOUT CONTRAST DUE TO HISTORY OF BACK PAIN, RIGHT-SIDED PAIN AND SCIATICA, SURGERIES AT L4-3, L4-5 AND L5-S1 LEVELS. THE RESULTS WERE COMPARED WITH THE X-RAY OF LUMBAR SPINE OF (B)(6) 2010. IMPRESSION: EXTENSIVE POST-OPERATIVE CHANGES WITH PEDICLE FIXATION DEVICES AT L3 AND L4, AND DISC SPACE DEVICES AT L3-4, L4-5, AND L5-S1. AT THE POST-OPERATIVE LEVELS OF L3-4, L4-5 AND L5-S1, NO RECURRENT DISC DISEASE AND NO SIGNIFICANT SPINAL OR NEURAL FORAMINAL STENOSIS IS SEEN. AT THE LEVEL OF L5-S1, MINIMAL LATERAL RECESS AND NEURAL FORAMINAL NARROWING IS SEEN DUE TO SOME FIBROSIS AND SCAR TISSUE, BUT NO SIGNIFICANT RECURRENT DISC DISEASE IS SEEN. THE MAIN ABNORMALITIES ARE L2-3 WITH POSTERIOR CENTRAL/RIGHT PARACENTRAL AND BILATERAL NEURAL FORAMINAL DISC PROTRUSIONS WITH SPINAL AND NEURAL FORAMINAL NARROWING, THE RIGHT SLIGHTLY MORE THAN LEFT, DUE TO A COMBINATION OF DISC BULGES, DISC PROTRUSION AND FACET JOINT ARTHROPATHY. NO ABNORMAL CONTRAST ENHANCEMENT. NO MASSES. ON (B)(6) 2012: THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE. IMPRESSION: STATUS POST FUSION AND INTERVERTEBRAL DISC REPAIR. SPONDYLOLISTHESIS WITH DEGENERATIVE CHANGES PROMINENT AT L2-L3. OSTEOPENIA WITH MILD WEDGE DEFORMITY AT L1. ON (B)(6) 2012: THE PATIENT UNDERWENT CT OF LUMBAR SPINE WITH CONTRAST DUE TO INDICATION OF LUMBOSACRAL SPONDYLOSIS. FINDINGS: CONTRAST WITHIN THE INTRA-THECAL SPACE IN THE LUMBAR REGION. IMPRESSION: SUCCESSFUL LUMBAR MYELOGRAM. MULTI-LEVEL DEGENERATIVE CHANGES AND POST-SURGICAL CHANGES. AT L2-3, THERE IS MILD CENTRAL SPINAL STENOSIS. THERE IS A SUPER-IMPOSED ASYMMETRIC LEFT FORAMINAL AND LATERAL DISC BULGE THAT CAUSES MILD LEFT NEURAL FORAMINAL STENOSIS. IN THE LEFT LATERAL ZONE, THE DISC CONTACTS AND DISPLACES THE EXISTING LEFT L2 NERVE ROOT. ON (B)(6) 2013: THE PATIENT PRESENTED WITH MULTIPLE OPERATED SPINE, SPINAL STENOSIS, POST-LAMINECTOMY KYPHOSIS. THE PATIENT UNDERWENT REMOVAL OF INSTRUMENTATION, EXPLORATION OF FUSION, L2 LAMINECTOMY, PARTIAL L1 LAMINECTOMY, L1, L2, L3 DECOMPRESSION, PARTIAL MEDIAL FASCIECTOMIES AND FORAMINOTOMIES, T10-L3 PONTE OSTEOTOMIES, T10-L5 INSTRUMENTATION, CORRECTION CLOSURE OF OSTEOTOMIES AND FUSION, L2-L3 RIGHT SIDED TRANS-FORAMINAL INTER-BODY FUSION WITH PEEK CAGE. NO PATIENT COMPLICATIONS WERE REPORTED. ON (B)(6) 2014: THE PATIENT PRESENTED WITH T9-10 DISC HERNIATION, RIGHT PARACENTRAL, DEGENERATIVE DISC DISEASE STATUS POST T10 TO THE ILIUM INSTRUMENTATION, CORRECTION AND FUSION. THE PATIENT UNDERWENT REMOVAL OF INSTRUMENTATION, EXPLORATION OF FUSION, RIGHT T9-T10 TRANSPEDICULAR DISCECTOMY, T5-T9 PONTE OSTEOTOMIES, T5-T12 INSTRUMENTATION AND T5-T11 FUSION. NO PATIENT COMPLICATIONS WERE REPORTED.
REPORTEDLY, THE PATIENT "DEVELOPED OVERGROWN BONE, EXPERIENCED SIGNIFICANT PAIN AND SUFFERED OTHER SERIOUS INJURIES."
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 | M110801AAF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |