INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-04241
- 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. 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 ON (B)(6) 2008, THE PATIENT PRESENTED WITH INCREASING BACK PAIN AND RIGHT LEG PAIN AND THE PREOPERATIVE DIAGNOSIS OF L4-5 AND L5-S1 DISKOGENIC DISK DISEASE, DISK DEGENERATIVE PAIN SYNDROME L4-5, L5-S1, POST LAMINECTOMY SYNDROME, PSEUDOARTHROSIS, AND INTRACTABLE BACK PAIN. IT WAS MENTIONED THAT X-RAYS HAD SHOWN SOME CALCIFICATION AT THE AORTA, NOT ALLOWING AN ANTERIOR APPROACH. A MRI HAD BASICALLY REVEALED DEGENERATIVE DISK DISEASE 4-5, 5-1 AND A DISCOGRAM HAD REVEALED CONCORDANT PAIN AT L4-5 AND L5-S1. THE PATIENT UNDERWENT SURGERY WHICH CONSISTED OF A L4-5, L5-S1 FUSION; EXPLORATION OF QUESTIONABLE PSEUDARTHROSIS; INSTRUMENTATION WITH MEDTRONIC¿S LEGACY PEDICLE SCREWS, PEEK SYSTEM, L4,L5, AND S1; REVISION LAMINECTOMY L4; LAMINECTOMY SUBTOTAL L5 AT PREVIOUS UNDECOMPRESSED SEGMENT; LAMINECTOMY SUBTOTAL S1 AT PREVIOUSLY UNDECOMPRESSED SEGMENT; RIGHT ILIAC CREST BONE GRAFTING THROUGH A SEPARATE FASCIAL INCISION; APPLICATION OF LOCAL AUTOGRAFT FOR POSTEROLATERAL FUSION; AND APPLICATION OF INFUSE WITH COMPRESSIVE RESISTANT MASTERGRAFT MATRIX FOR POSTEROLATERAL FUSION. PER THE OPERATIVE NOTES ¿¿IT WAS NOTED THAT THERE WAS MINIMAL MOTION AT L4-5 WHERE I FELT THIS WAS NOT A SOLID FUSION. IT LOOKED LIKE SHE HAD A POSSIBLE FACET FUSION, BUT I ELECTED TO GO AHEAD AND RE-INSTRUMENT. THERE WAS SIGNIFICANT INSTABILITY AT L5-S1. L3-4 WAS FAIRLY MOBILE, BUT CERTAINLY NOT UNSTABLE WITH NO SPONDYLOLISTHESIS. THEREFORE, I ELECTED TO INSTRUMENT L4-5 AND L5- S1 SECONDARY TO THE INSTABILITY, THE CONCORDANT DISCOGRAPHY AND HER RIGHT LEG PAIN WITH GRADE 5 ANNULAR TEAR/ DDC ON THE RIGHT AT L4-5¿. NEXT, A 5.5 MM X 45 MM SCREW WAS INSERTED AND TESTED AND FOUND TO BE GREATER THAN 20. THE SAME PROCEDURE WAS PERFORMED AT L5 USING 5.5 MM SCREW AND S1 USING A 6.5 X 35 MM. THE LEFT S1 SCREW TESTED AT 13. I REPALPATED THIS. THERE WAS NO BREACH OF THE PEDICLE CORTEX IN ANY DIRECTION AND IT WAS VERY CLOSE TO THE SACRAL ALA ANTERIORLY AND THEREFORE, I FELT IT WAS LIKELY TESTING THROUGH THE¿..TISSEEL WAS THEN PLACED OVER EXPOSED DURA PRIOR TO BURRING DOWN TO PREVENT THE INGROWTH OF INFUSE AND TO PROTECT THE NERVES FROM SCARRING. TWO 50 MM PEEK RODS WERE THEN PLACED. SET SCREWS WERE SHEARED OFF¿I NEXT BURRED DOWN THE FACET JOINT AT 4-5 AND 5-S1, AS WELL AS THE LATERAL PARS OF 4 AND 5 ON THE LEFT. I ALSO BURRED DOWN THE REMAINDER OF THE LAMINA OF L4, L5 AND S1. NEXT, THE INFUSE WITH COMPRESSIVE-RESISTANT MASTERGRAFT MATRIX WAS PLACED IN THE POSTEROLATERAL GUTTERS AND TRANSVERSE PROCESS OF L4, L5 AND S1. OSTEOFIL MIXED WITH LOCAL BONE FROM THE DECOMPRESSION AND ILIAC CREST ASPIRATE WAS PLACED DORSAL AND LATERAL TO THIS. THE CANCELLOUS BONE FROM THE ILIAC CREST WAS PLACED IN THE FACET JOINTS ON THE LEFT SIDE AT 4-5 AND 5-S1. THE REMAINDER OF THE INFUSE WAS PLACED OVER THE FACET JOINTS AT 4-5 AND 5-S1 AND OVER THE LAMINA OF 4-5 AND S1. THE REMAINDER OF THE OSTEOFIL MIXED WITH LOCAL BONE FROM THE DECOMPRESSION AND ILIAC CREST ASPIRATE WAS PLACED ON TOP OF THIS AS WELL¿¿ NEURO-MONITORING, FLUOROSCOPY PY, AND X-RAYS WERE UTILIZED FOR VERIFICATION AND PLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED. ON (B)(6) 2009 THE PATIENT PRESENTED WITH THE DIAGNOSIS OF CHRONIC PAIN SYNDROME, MECHANICAL COMPLICATION OF THE THECAL PUMP, POST LAMINECTOMY SYNDROME, AND LUMBAR RADICULITIS. THE PATIENT HAD AN INTRA-THECAL INFUSION PUMP FOR PAIN AND UNDERWENT A PROCEDURE FOR THE ANALYSIS, REFILL AND REPROGRAMMING OF IT. NO PATIENT COMPLICATIONS WERE REPORTED. ON (B)(6) 2009, (B)(6) 2010, (B)(6) 2011, (B)(6) 2012, THE PATIENT PRESENTED WITH THE DIAGNOSIS OF CHRONIC PAIN SYNDROME AND FAILED SURGERY SYNDROME, LUMBAR RADICULITIS. THE PATIENT HAD AN INTRA-THECAL INFUSION PUMP FOR PAIN AND UNDERWENT A PROCEDURE FOR THE ANALYSIS, REFILL AND REPROGRAMMING OF IT. NO PATIENT COMPLICATIONS WERE REPORTED. ON (B)(6) 2010 THE PATIENT PRESENTED WITH CERVICAL RADICULITIS, CERVICAL DISC DEGENERATION, CERVICAL SPONDYLOSIS, AND LEFT KNEE BAKERS CYST. THE PATIENT UNDERWENT A CERVICAL TRANS-FORAMINAL EPIDURAL STEROID INJECTION C6-7 AND LEFT KNEE BAKER¿S CYST ASPIRATION. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2010 THE PATIENT PRESENTED WITH CERVICAL RADICULITIS, CERVICAL DISC DEGENERATION, AND CERVICAL SPONDYLOSIS AND UNDERWENT A CERVICAL TRANS-FORAMINAL EPIDURAL STEROID INJECTION C6-7. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2010 THE PATIENT PRESENTED WITH THE PREOPERATIVE DIAGNOSIS OF LEFT KNEE INTERNAL DERANGEMENT AND THE POST-OPERATIVE DIAGNOSIS OF LEFT KNEE: MEDIAL MENISCUS TEAR; LATERAL MENISCUS TEAR; DEGENERATIVE ARTHRITIS; AND SYNOVITIS. THE PATENT UNDERWENT A PARTIAL MEDIAL MENISCECTOMY, PARTIAL LATERAL MENISCECTOMY, PARTIAL SYNOVECTOMY, AND PATELLA-FEMORAL AND MEDIAL COMPARTMENT CHONDROPLASTY. NON PATIENT COMPLICATIONS WERE NOTED. ON (B)(60 2010 THE PATIENT PRESENTED WITH THE DIAGNOSIS OF CHRONIC PAIN SYNDROME, MECHANICAL COMPLICATION, POST LAMINECTOMY SYNDROME, AND LUMBAR RADICULITIS. THE PATIENT HAD AN INTRA-THECAL INFUSION PUMP FOR PAIN AND UNDERWENT A PROCEDURE FOR THE ANALYSIS, REFILL AND REPROGRAMMING OF IT. NO PATIENT COMPLICATIONS WERE REPORTED. ON (B)(6) 2010 THE PATIENT PRESENTED FAILED SYNDROME AND LUMBAR RADICULITIS. THE PATIENT UNDERWENT A LUMBAR TRANS-FORAMINAL EPIDURAL INJECTION AT L3-4. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2011 THE PATIENT PRESENTED WITH LOW BACK PAIN, LUMBAR DISC DEGENERATION, AND LUMBAR RADICULITIS. THE PATIENT UNDERWENT A LUMBAR PROVOCATIVE DISCOGRAPHY L1-2, L2-3, AND L3-4 WHICH DEMONSTRATED MODERATE DEGENERATION AT L3-4 WITH ANTERIOR AND POSTERIOR FISSURING AND EPIDURAL SPREAD OF CONTRAST CONCORDANT PAIN AT L3-4 LEVEL. L1-L2 AND L2-3 WERE NORMAL. ON (B)(6) 2011 THE PATIENT PRESENTED WITH LOW BACK PAIN, LUMBAR DISC DEGENERATION, AND LUMBAR RADICULITIS. THE PATIENT UNDERWENT BILATERAL LUMBAR TRANS-FORAMINAL EPIDURAL INJECTIONS. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2011 THE PATIENT PRESENTED WITH LOW BACK PAIN, LUMBAR DISC DEGENERATION, AND LUMBAR SPONDYLOSIS. THE PATIENT UNDERWENT A BILATERAL DIAGNOSTIC FACET MEDIAL BRANCH BLOCK AT L2. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2011 THE PATIENT PRESENTED WITH LUMBAR DISC DEGENERATIVE DISC DISEASE @ L3-4 AND LOWER BACK PAIN. THE PATIENT UNDERWENT A BIACUPLASTY OF L3-4 DISK. NO PATIENT COMPLICATIONS WERE REPORTED. X-RAYS WERE UTILIZED FOR VERIFICATION. THE PATIENT WAS TO WEAR A SOFT LUMBAR BRACE FOR 6 WEEKS FOLLOWING THE PROCEDURE. ON (B)(6) 2011 THE PATIENT PRESENTED WITH CERVICAL RADICULITIS, CERVICAL DISC DEGENERATION, AND CERVICAL SPONDYLOSIS AND UNDERWENT A CERVICAL TRANS-FORAMINAL EPIDURAL STEROID INJECTION C6-7. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2012 THE PATIENT PRESENTED WITH CHRONIC PAIN SYNDROME, LUMBAR DISC DEGENERATION, LOW BACK PAIN, LUMBAR SPONDYLOSIS, AND COCCYDYNIA. THE PATIENT UNDERWENT A CAUDAL EPIDURAL INJECTION. NO PATIENT COMPLICATIONS WERE NOTED. ON (B)(6) 2012. THE PATIENT PRESENTED WITH THE DIAGNOSIS OF CHRONIC PAIN SYNDROME, FAILED SURGERY SYNDROME, AND LUMBAR RADICULITIS. THE PATIENT UNDERWENT AN INTRA-THECAL INFUSION FOR CHRONIC PAIN. NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712707 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110710AAF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |