INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-00906
- Event Type
- Injury
- Date Received
- April 2, 2013
- Report Date
- July 27, 2015
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT
Narratives
(B)(4).
(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.
IT WAS REPORTED THAT THE PATIENT IS "UNABLE TO LIVE MY LIFE OR GO BACK TO WORK" DUE TO RHBMP-2/ACS. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT ON (B)(6) 2000: PATIENT HAD PAIN ON LEFT HAND SIDE AND THE BACK OF THE LEG. ON (B)(6) 2000: PATIENT PRESENTED WITH LOW BACK PAIN. ON (B)(6) 2000, (B)(6) 2010, (B)(6) 2000: PATIENT PRESENTED FOR AN OFFICE VISIT. ON (B)(6) 2000: PATIENT PRESENTED FOR CHIEF COMPLAINT OF CONSTANT BILATERAL LOW BACK PAIN AND HIP PAIN. ON (B)(6) 2009: PATIENT UNDERWENT C-SPINE EXAMINATION. 21 NOV 2009: PATIENT WAS EXAMINED FOR AN INJURY THAT HE HAD ON (B)(6) 2009. ON THAT DAY PATIENT WALKED ONTO A WET SURFACE AND SLIPPED. THE PATIENT WAS DIAGNOSED WITH CERVICAL STRAIN AND LEFT TRAPEZIUS STRAIN. ALSO PATIENT HAD LIMITED RANGE OF MOTION WITH NECK. ON (B)(6) 2010: PATIENT UNDERWENT X-RAY OF L-SPINE DUE TO INJURY. IMPRESSION: FRACTURES ARE NOT IDENTIFIED (B)(6) 2010: PATIENT PRESENTED WITH A CHIEF COMPLAINT OF LEFT HIP PAIN. ASSESSMENT: LEFT HIP CONTUSION. ON (B)(6) 2010: PATIENT PRESENTED FOR LOW BACK PAIN RADIATING TO BUTTOCKS AND TO LEFT LEG. ON (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW-UP VISIT FOR RECHECKING OF THE LEFT HIP AND LOW BACK. PATIENT ALSO STATED LOW BACK PAIN RADIATING TO LEFT LEG. ASSESSMENT: LUMBAR STRAIN, POSSIBLE DISC HERNIATION (B)(6) 2010: PATIENT PRESENTED WITH A CHIEF COMPLAINT OF BACK PAIN. IMPRESSION: PERSISTENT LOW BACK PAIN (B)(6) 2010: PATIENT PRESENTED FOR LOW BACK PAIN. PATIENT UNDERWENT THE MR OF LUMBAR SPINE WITHOUT CONTRAST BECAUSE OF LUMBAR STRAIN. STATUS POST FALL. IMPRESSION: PROTRUDING DISC AT L5-S1 WITH SMALL COMPONENT OF ANNULAR TEAR SUSPECTED. ON (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW-UP VISIT FOR MRI OF THE BACK. ASSESSMENT: L5-S1 ANNULAR TEAR AND MILD BIFORAMINAL NARROWING. LOW BACK STRAIN. ON (B)(6) 2010: PATIENT PRESENTED FOR CONSTANT BUTTOCK AND LOW BACK PAIN. ON (B)(6) 2010: PREPROCEDURE DIAGNOSIS: LUMBAR ANNULAR TEAR. PATIENT UNDERWENT FOLLOWING PROCEDURE: LUMBAR INTERLAMINAR EPIDURAL INJECTION AT THE L5-S1 INTERSPACE (B)(6) 2010: PATIENT PRESENTED FOR FOLLOW-UP VISIT FOR LOW BACK PAIN. ON (B)(6) 2010: PATIENT PRESENTED WITH PAIN RADIATING TO LEGS. ON (B)(6) 2010: PATIENT CALLED FOR CHANGE IN MEDICATIONS. ON (B)(6) 2010: PATIENT UNDERWENT CCT LUMBAR SPINE WITHOUT CONTRAST DUE TO BACK PAIN. IMPRESSION: THE INJECTION AT L5-S1 REPRODUCED BACK PAIN WITH RADIATION INTO THE LEFT BUTTOCK. THE PATIENT STATED THAT THIS WAS 100% SIMILAR TO HER DAILY PAIN. ON POST DISCOGRAM CT THE DISC WAS DEGENERATED WITH A MILD DIFFUSE DISC BULGE. NO MASS EFFECT ON THE LEFT EXISTING L5 NERVE ROOT AND THERE IS NO SPINAL CANAL STENOSIS; AT L3-L4 THE PATIENT EXPERIENCED SEVERE BACK PAIN ISOLATED TO THE LOWER BACK WHICH STATED WAS APPROXIMATELY 80% SIMILAR TO DAILY PAIN. ON THE POST DISCOGRAM CT THERE WAS A POSTERIOR ANNULAR TEAR WITH A SMALL CENTRAL DISC PROTRUSION. NO SPINAL CANAL ORNEUROFORAMINAL STENOSIS; L4-L5 DISC IS NORMAL (B)(6) 2010: PATIENT PRESENTED WITH A CHIEF COMPLAINT OF BACK PAIN. ON (B)(6) 2011: PATIENT PRESENTED WITH A CHIEF COMPLAINT OF LOW BACK PAIN. PRE-OPERATIVE DIAGNOSIS: MECHANICAL LOW BACK PAIN. L5-S1 DISCO GENIC PAIN. PATIENT UNDERWENT FOLLOWING PROCEDURES: L5-S1 TRANS SACRAL DISCECTOMY WITH FLUOROSCOPIC GUIDANCE. ARTHRODESIS, L5-SI, USING AUTO GRAFT, ALLOGRAFT, AND BONE MORPHOGENIC PROTEIN (BMP). PLACEMENT OF AXIAL IF SCREW, L5-S 1, USING 50 X 10 X 12MMSCREW WITH FLUOROSCOPIC GUIDANCE. TELLURIDE PERCUTANEOUS PEDICLE SCREW PLACEMENT, L5-S1 BILATERALLY, USING 6.5 X 45 MM SCREWS AT S 1, AND 6.5 X 50MM SCREWS AT L5 WITH FLUOROSCOPIC GUIDANCE. CONTINUOUS SOMATOSENSORY EVOKED POTENTIAL AND ELECTROMYOGRAM MONITORING WITH SCREW TESTING. PER OP NOTES, THE SURGEON GOT A GOOD REMOVAL OF THE DISC AND CLEANED OUT THE DISC SPACE. THE SURGEON ALSO PLACED PEDICLE SCREWS. THE SURGEON ALSO USED 6.5 X 50 MM SCREWS AT L5 WITH 45 MM SCREWS AT S1. ONCE THIS WAS DONE, SURGEON COPIOUSLY IRRIGATED WITH BACITRACIN. THEN FILLED THE DISC SPACE WITH THE ALLOGRAFT, AUTOGRAFT, AND SOME BMP WHICH HAD BEEN MIXED EARLIER. THE SURGEON PACKED THIS TIGHTLY. PATIENT UNDERWENT RADIOLOGY EXAM OF LUMBAR SPINE. IMPRESSION: L5-S1 FUSION. PATIENT ALSO UNDERWENT RADIOLOGY EXAM C-ARM. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2011: PATIENT PRESENTED FOR CHIEF COMPLAINT OF LOWER BACK, RIGHT BUTTOCK AND LEG PAIN. ON (B)(6) 2011: PATIENT PRESENTED FOR PHYSICAL THERAPY. ON (B)(6) 2011: PATIENT PRESENTED WITH CHIEF COMPLAINT OF SURGICAL WOUND DRAINING (B)(6) 2011: PATIENT PRESENTED WITH CHIEF COMPLAINT OF STATUS POST L5-S1 FUSION. PATIENT ALSO UNDERWENT RADIOLOGY EXAM OF LUMBAR SPINE DUE TO LOW BACK PAIN. CONCLUSION: UNREMARKABLE L5-S1 FUSION. ON (B)(6) 2011: PATIENT PRESENTED WITH CHIEF COMPLAINT OF CHRONIC BACK PAIN. ON (B)(6) 2011: PATIENT PRESENTED FOR AN OFFICE VISIT. PATIENT ALSO UNDERWENT RADIOLOGY EXAM OF LUMBAR SPINE DUE TO PAIN. IMPRESSION: STATUS POST ANTERIOR AND POSTERIOR FUSION L5-S1 WITHOUT ABNORMAL MOVEMENT IDENTIFIED. ON (B)(6) 2011: PATIENT PRESENTED WITH CHIEF COMPLAINT OF BACK PAIN. PATIENT ALSO UNDERWENT RADIOLOGY EXAM OF LUMBAR SPINE. CONCLUSION: UNREMARKABLE POSTOP LUMBAR SPINE. ON (B)(6) 2011: PATIENT STATED THAT HER HIPS WERE SORE BUT FEELS LIKE THE PAIN WAS GETTING BETTER. ON (B)(6) 2011: PATIENT PRESENTED WITH PAIN AND ALSO APPEARED TO HAVE TENDERNESS. ON (B)(6) 2011: PATIENT PRESENTED WITH CHIEF COMPLAINT OF IMPROVING BACK PAIN. ON (B)(6) 2011: PATIENT PRESENTED WITH COMPLAINT OF PAIN. ON (B)(6) 2011: PATIENT PRESENTED WITH CHIEF COMPLAINT OF LOWER BACK, BUTTOCKS, BILATERAL HIP AND LEG PAIN. PATIENT HAD A SWELLING AND CHANGE IN APPETITE. ON (B)(6) 2011: PATIENT PRESENTED WITH CHIEF COMPLAINT OF LOWER BACK, BUTTOCKS, BILATERAL HIP AND LEG PAIN. ON (B)(6) 2011: PATIENT PRESENTED WITH CHIEF COMPLAINT OF LUMBAR FUSION AND LOW BACK PAIN. ON (B)(6) 2011: PATIENT PRESENTED WITH CHIEF COMPLAINT OF INCREASING LOW BACK PAIN WITH RIGHT LEG PAIN. PATIENT ALSO UNDERWENT RADIOLOGY EXAM OF LUMBAR SPINE DUE TO LOW BACK PAIN. CONCLUSION: NEW FRACTURE OF ONE OF THE TWO S1 SCREWS. OTHERWISE NO INTERVAL CHANGE. ON (B)(6) 2011: PATIENT PRESENTED WITH CHIEF COMPLAINT OF PAIN EXTENDING DOWN IN RIGHT LEG. THE PAIN WAS WORSENING SINCE THREE MONTHS. ON (B)(6) 2011: PATIENT ALSO UNDERWENT RADIOLOGY EXAM OF LUMBAR MYELOGRAM DUE TO LOW BACK PAIN AND RIGHT LEG PAIN. IMPRESSION: STATUS POST L5-S1 ANTERIOR AND POSTERIOR FUSION. FRACTURE OF ONE OF THE SCREWS THROUGH THE SACRUM. NO SIGNIFICANT SPINAL STENOSIS OR NERVE ROOT IMPINGEMENT AT ANY LEVEL. PATIENT ALSO UNDERWENT POST MYELOGRAM/ POST CONTRAST CT OF THE LUMBAR SPINE. IMPRESSION: FRACTURE OF THE LEFT S1 SCREW. THE BOLT THROUGH L5 APPEARS LOOSE. NO SUBLUXATIONS. NO SIGNIFICANT SPINAL STENOSIS AT ANY LEVEL. MILD SPONDYLOSIS IN THE LUMBAR SPINE WITH TINY ANTERIOR OSTEOPHYTES. ON (B)(6) 2012: PATIENT PRESENTED WITH CHIEF COMPLAINT OF BACK AND RIGHT LEG PAIN. ON (B)(6) 2012: PREOPERATIVE DIAGNOSES: LOW BACK PAIN WITH RIGHT LEG PAIN; PSEUDO ARTHROSIS L5-S1 WITH INSTRUMENTATION FAILURE. FOLLOWING PROCEDURE WAS PERFORMED: EXPLORATION OF LS-S1 FUSION; REMOVAL OF LS-S1 SILHOUETTE INSTRUMENTATION INCLUDING BILATERAL LS AND S1 PEDICLE SCREWS, TWO RODS AND OBSERVATION OF FRACTURE OF LEFT SI SCREW; LS LAMINECTOMY WITH BILATERAL L5 AND S1 FORAMINOTOMIES AND BILATERAL L5 AND S1 NERVE ROOT DECOMPRESSIONS; PLIF L5-S1 USING AUTO GRAFT PLUS BMP; L5-S1 PEDICLE SCREW FIXATION USING SILVERTON/LANX SYSTEM USING 7.5 X 50 MM SCREWS AT L5 AND 7.5 X 45 MM SCREWS AT S1 WITH TITANIUM RODS AND CROSSLINK; CONTINUOUS SSEP AND EMG MONITORING AND SCREW TESTING. PER OP NOTES, THE SURGEON INCISED THE DISK SPACE ON THE LEFT SIDE INITIALLY WITH IS-BLADE AND THEN WENT INTO THIS SPACE WITH SHAVER, SIZE 8-10 MM. THE SURGEON COULD FEEL THE AXIALIF SCREW IN THE MIDLINE BUT WAS ABLE TO REMOVE DISK MATERIAL AROUND IT AND ANTERIORLY WITH THE SHAVERS AS WELL AS A RING CURETTE. THE SURGEON DID THE SAME THING ON THE RIGHT SIDE. BECAUSE OF A LIMITED SPACE, THE SURGEON DECIDED NOT TO PLACE ANY HOUR GLASS SPACERS BUT FILLED THE DISK SPACE WITH A LARGE AMOUNT OF BONE WHICH HAD BEEN MULCHED UP FROM THE DECOMPRESSION AS WELL AS BMP WHICH WAS MIXED IN AND PLACED MORE ANTERIORLY. THIS WAS PACKED IN TIGHTLY ON BOTH SIDES AND THE DISK SPACE WAS, AT THIS POINT, FULL OF BONE. THE SURGEON THEN PLACED BMP WRAPPED AROUND AUTOGRAFT OVER THE DECORTICATED TRANSVERSE PROCESSES AT L5 AND S1 BILATERALLY. THE SURGEON PACKED MORE BONE AROUND THIS. THEN PLACED THE RODS ONTO THE SCREWS, TIGHTENED THESE DOWN AT L5 AND THEN COMPRESSED SLIGHTLY BETWEEN L5 AND S1 AND TIGHTENED THEM AT S1. THEN SURGEON PLACED A CROSSLINK IN THE STANDARD FASHION WITHOUT DIFFICULTY. THE SURGEON USED THE 6.5 X 50 MM SCREWS AT L5 WITH 45 MM SCREWS AT S1. ESTIMATED BLOOD LOSS OF THE PROCEDURE WAS 300 ML. PATIENT ALSO UNDERWENT RADIOLOGY EXAM OF LUMBAR SPINE DUE TO REVISION L4-L5. FINDINGS: REVISION OF L5-S1 ANTERIOR AND POSTERIOR LUMBAR FUSION WITH PEDICLE SCREWS AND ANTERIOR INTER BODY FUSION SCREW. WIDE LAMINECTOMY. OVERLYING DRAINAGE CATHETER. ANATOMIC ALIGNMENT. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2012: PATIENT ALSO UNDERWENT RADIOLOGY EXAM OF LUMBAR SPINE. IMPRESSION: UNREMARKABLE POSTERIOR LUMBAR SPINAL FUSION OF L5 AND S1. ON (B)(6) 2012: PATIENT PRESENTED WITH CHIEF COMPLAINT OF BACK PAIN. PATIENT ALSO UNDERWENT RADIOLOGY EXAM OF LUMBAR SPINE DUE TO LUMBAGO. CONCLUSION: UNREMARKABLE L5-S1 FUSION. ON (B)(6) 2012: PATIENT PRESENTED WITH CHIEF COMPLAINT OF BACK PAIN, WORSE WITH PROLONGED SITTING. PATIENT ALSO UNDERWENT RADIOLOGY EXAM OF LUMBAR SPINE DUE TO LOW BACK PAIN CONCLUSION: STATUS POST POSTERIOR FUSION OF L5-S1 WITHOUT EVIDENCE OF ABNORMAL MOTION. ON (B)(6) 2012: PATIENT PRESENTED WITH CHIEF COMPLAINT OF LOW BACK PAIN AND ACROSS HER HIPS. PATIENT ALSO UNDERWENT RADIOLOGY EXAM OF LUMBAR SPINE DUE TO BACK PAIN AND FUSION. IMPRESSION: STABLE HARDWARE AND ALIGNMENT. ON (B)(6) 2012: PATIENT PRESENTED WITH CHIEF COMPLAINT OF LOW BACK AND LEG PAIN. ON (B)(6) 2013: PATIENT PRESENTED WITH CHIEF COMPLAINT OF MILD BACK PAIN. PATIENT ALSO UNDERWENT RADIOLOGY EXAM OF LUMBAR SPINE DUE TO PAIN. IMPRESSION: STABLE SURGICAL HARDWARE AND ALIGNMENT. ON (B)(6) 2013: PATIENT PRESENTED WITH CHIEF COMPLAINT OF WORSENING PAIN, BACK AND LEGS. ON (B)(6) 2013: PATIENT PRESENTED WITH CHIEF COMPLAINT OF INCREASED BACK AND LEG PAIN. ON (B)(6) 2013: PATIENT UNDERWENT MRI OF THE LUMBOSACRAL SPINE WITH AND WITHOUT CONTRAST DUE TO LOW BACK PAIN WITH BILATERAL LOWER EXTREMITY RADICULOPATHY, STATUS POST LUMBAR FUSION SCREW REPAIR. CONCLUSION: STATUS POST INTER BODY FUSION L5-S1 WITH PEDICLE SCREW FIXATION AT L5 AND S1. MILD TO MODERATE SPINAL CANAL STENOSIS AT L4-L5 SECONDARY TO HYPERTROPHIC FACET OSTEOARTHRITIS AT L4-5. OTHERWISE NEGATIVE LUMBAR MRI. ON (B)(6) 2013: PATIENT PRESENTED WITH CHIEF COMPLAINT OF LOW BACK AND RIGHT GREATER THAN LEFT LEG PAIN. ON (B)(6) 2013: PATIENT PRESENTED WITH CHIEF COMPLAINT OF MUSCLE SPASM. PHYSICAL EXAMINATION REVEALED MILD TENDERNESS TO PALPATION. ON (B)(6) 2013: PATIENT PRESENTED WITH CHIEF COMPLAINT OF CHRONIC BACK PAIN.
IT WAS REPORTED BY THE PATIENT THAT "...THE DEVICE THAT WAS IMPLANTED IN MY SPINE TO FUSE THE DISC ... IT'S THE ONLY REASON I'M IN CONSTANT CHRONIC PAIN AND THE REASON I'M NO LONGER ABLE TO WORK...¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134645 | 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 | Other |