INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-02904
- Event Type
- Injury
- Date Received
- June 25, 2014
- Report Date
- June 18, 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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT ON (B)(6) 2000 PATIENT UNDERWENT MRI OF LUMBAR SPINE DUE TO LOW BACK PAIN RADIATING DOWN LEFT LEG. IMPRESSION: DIFFUSE DISC BULGING WITH CENTRAL PROTRUSION AT L4-5. A LEFT PARACENTRAL EXTRUDED DISC FRAGMENT WAS ALSO SEEN, WITH MASS EFFECT ON THE LEFT L5 NERVE ROOT. ON (B)(6) 2000 PATIENT UNDERWENT MRI OF LUMBAR SPINE. IMPRESSION: STATUS POST SURGICAL CHANGES AT THE L4-5 LEVEL. SMALL AREA FOLLOWING FLUID CHARACTERISTICS WAS SEEN ON THE LEFT SURROUNDED BY ENHANCING PROBABLE GRANULATION TISSUE NEAR BUT AND APPEARING TO COMMUNICATE AT THIS TIME WITH THE THECAL SAC. POST-SURGICAL CHANGES SUCH AS WITH SEROMA CAN GIVE THIS APPEARANCE. INFLAMMATORY/INFECTIOUS PROCESS OR EVEN A SMALL AMOUNT OF CSF FLUID CANNOT BE EXCLUDED ON THE BASIS OF THIS STUDY AND CLINICAL CORRELATION AS WELL AS LAB CORRELATION WAS RECOMMENDED. ON (B)(6) 2001 PATIENT UNDERWENT MRI OF LUMBAR SPINE WITHOUT AND WITH CONTRAST. IMPRESSION: POST SURGICAL CHANGES INVOLVING L5, MILD LEFT PARACENTRAL L3-4 AND L4-5 DISC BULGES. ON (B)(6) 2001, (B)(6) 2005 PATIENT PRESENTED FOR AN OFFICE VISIT. ON (B)(6) 2003, (B)(6) 2004 PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. ON (B)(6) 2005 PATIENT PRESENTED WITH LEG PAIN, LEFT BUTTOCK PAIN. ON (B)(6) 2005 PATIENT UNDERWENT MRI OF THE LUMBAR SPINE. IMPRESSION: AT L4-5 THERE HAD BEEN LEFT L4 LAMINECTOMY. THERE WERE POSTSURGICAL CHANGES IN THE POSTERIOR DISC, WITHOUT EVIDENCE FOR RESIDUAL OR RECURRENT HERNIATION OR CANAL STENOSIS. THERE WAS MILD FORAMINAL STENOSIS WITH SLIGHT ENCROACHMENT ON THE L4 NERVE ROOTS, POSSIBLE WORSENING WITH WEIGHTBEARING. NO EVIDENCE FOR SIGNIFICANT NEURAL TETHERING BY GRANULATION TISSUE, INFECTION OR MALIGNANCY. THERE WAS NO RECENT DISC HERNIATION, LISTHESIS, OR ENDPLATE COMPRESSION. MILD LUMBAR LEVOSCOLIOSIS (B)(6) 2005 PATIENT PRESENTED DUE TO LEFT S1 JOINT ARTHROGRAM AND BLACK. IMPRESSION: LEAKING JOINT POSTERIORLY. NO RELIEF OF THE PATIENT'S TYPICAL PAIN SYMPTOMS. ON (B)(6) 2005 PATIENT UNDERWENT AN INJECTION INTO THE SACROILIAC JOINT. ON (B)(6) 2005 PATIENT PRESENTED FOR AN OFFICE VISIT. ON (B)(6) 2005 PATIENT UNDERWENT L4-5 DISCOGRAM AND DISC INJECTION. IMPRESSION: ANTERIOR LEAK L4-5. MILD NUCLEAR DEGENERATION. PAIN REPRODUCTION, BUT NO PAIN RELIEF. ON (B)(6) 2005 PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO LOW BACK PAIN. ON (B)(6) 2006 PATIENT UNDERWENT AN INTRADISCAL INJECTION. ON (B)(6) 2006 PATIENT PRESENTED FOR AN OFFICE VISIT. ON (B)(6) 2006 PATIENT PRESENTED DUE TO SPINE, NERVE ROOT BLOCK 1 VIEW. ON (B)(6) 2006 PATIENT UNDERWENT CT SPINE L POST DISCOGRAM. ON (B)(6) 2006 PATIENT PRESENTED FOR AN OFFICE VISIT. ON (B)(6) 2006 PATIENT UNDERWENT AN X-RAY OF CHEST PA <(>&<)> LATERAL. ON (B)(6) 2006 THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR LUMBAR INTERBODY SPINAL FUSION, L4-5, L5-S1 USING FEMORAL RING ALLOGRAFT, BMP AND TENSION BAND PLATES TO TREAT THE FOLLOWING PRE-OP DIAGNOSIS: LOW BACK AND LEFT BUTTOCK PAIN. PER OP-NOTES: "AN 11MM FEMORAL RING, WHICH HAD BEEN ESPECIALLY MACHINED AND PREPARED, WAS THEN BROUGHT ONTO THE FIELD AND FILLED WITH BMP SPONGE. BEFORE PUTTING THE FEMORAL RING IN PLACE, WE DEVELOPED THE EXPOSURE FOR THE TOP OF THE SACRUM WHERE WE WERE GOING TO PUT OUR TWO ANTERIOR SCREWS...ON (B)(6) 2006 THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: EXPOSURE OF L4-S1 TO TREAT THE FOLLOWING PRE-OP DIAGNOSIS: BACK PAIN. ON (B)(6) 2006 PATIENT UNDERWENT ABDOMEN 2 VIEW AND ERECT CHEST. IMPRESSION: DISTENSION OF THE COLON WITH AIR WITHOUT PATHOLOGIC DILATATION. THIS COULD REFLECT MILD ILEUS BUT WAS NONSPECIFIC. ON (B)(6) 2006 PATIENT UNDERWENT CT OF LUMBAR SPINE WITHOUT CONTRAST DUE TO FOLLOW-UP LUMBOSACRAL FUSION FOUR DAYS AGO. IMPRESSION: TRANSLATIONAL ANATOMY WITH INTERBODY FUSION AND SCREW PLATE FIXATION. ON (B)(6) 2006 PATIENT UNDERWENT CT OF LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: TRANSITIONAL ANATOMY WITH INTERBODY FUSION AND SCREW PLATE FIXATION L5-6 AND L6-S1. ON (B)(6) 2006 PATIENT DISCHARGED FROM HOSPITAL. ON (B)(6) 2006 PATIENT UNDERWENT CT OF ABDOMEN AND PELVIS WITH CONTRAST DUE TO NONSPECIFIC LEFT SIDED ABDOMINAL PAIN. ON (B)(6) 2006 PATIENT PRESENTED FOR AN OFFICE VISIT. IMPRESSION: ESSENTIALLY NORMAL POSTOPERATIVE EXAMINATION SHOWING CHANGES OF ANTERIOR L4-5 AND L5-S1 FUSION. PROBABLE MUCOSAL REDUNDANCY OF THE SIGMOID COLON. NO DISCRETE OBSTRUCTION OR FOCAL BOWEL ABNORMALITY. ON (B)(6) 2006 PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO PAIN. ON (B)(6) 2006 PATIENT PRESENTED FOR AN OFFICE VISIT. ON (B)(6) 2006 PATENT UNDERWENT CT SCAN OF LUMBAR SPINE WITHOUT CONTRAST. ON (B)(6) 2006 PATENT UNDERWENT CT SCAN. ON (B)(6) 2006 PATIENT UNDERWENT TRIGGER POINT INJECTION. ON (B)(6) 2006 PATIENT UNDERWENT CT SCAN. ON (B)(6) 2006 PATIENT UNDERWENT CT GUIDED NEEDLE BIOPSY DUE TO PERSISTENT BACK PAIN, POST LOWER SPINAL FUSION. ON (B)(6) 2006 PATIENT PRESENTED DUE TO BACK PAIN. ON (B)(6) 2006, (B)(6) 2007 PATIENT PRESENTED FOR AN OFFICE VISIT. ON (B)(6) 2007 PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO PAIN. ON (B)(6) 2007 PATIENT PRESENTED DUE TO SPINE, NERVE ROOT BLOCK 1 VIEW DUE TO POST LOWER LUMBAR FUSION, PERSISTENT LEFT LEG PAIN. ON (B)(6) 2007 PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO PAIN. ON (B)(6) 2007 PATIENT UNDERWENT AN S1 INJECTION. ON (B)(6) 2007 PATIENT PRESENTED DUE TO PAIN. ON (B)(6) 2007 PATIENT PRESENTED DUE TO BUTTOCK AND LOWER BACK PAIN. ON (B)(6) 2007 PATIENT UNDERWENT MRI OF LUMBAR SPINE WITHOUT CONTRAST DUE TO LOWER BACK PAIN RADIATING INTO LEGS. STATUS POST LUMBAR SPINE FUSION ON 06 APR. IMPRESSION: PATIENT DOES HAVE TRANSITIONAL ANATOMY. NUMBERING UTILIZED FOR THIS EXAM ASSUMED THE HARDWARE TO BE AT L4-5 AND L5-S1, PATIENT IS STATUS POST ANTERIOR FUSION AT L4-5 AND L5-S1. PATIENT IS STATUS POST LEFT HEMILAMINECTOMY AT L4-5. CORRELATION WITH CT OR PLAIN FILM WOULD BE BETTER ABLE TO EVALUATE HARDWARE AND STATUS OF FUSION, THERE WAS NO CANAL STENOSIS OR NEURAL FORAMINAL NARROWING. THERE WAS A TINY LEFT FORAMINAL DISC PROTRUSION AT L2-3. CORRELATION WITH ANY SYMPTOMS OF LEFT L2 RADICULOPATHY WAS RECOMMENDED. MILD LATERAL RECESS STENOSIS FOR EACH S1 ROOT, PRIMARILY RELATED TO OSTEOPHYTES FROM THE ADJACENT FACET JOINT. CORRELATION WITH ANY S1 RADICULOPATHY WAS RECOMMENDED. TINY 4MM, CYST IN THE ANTERIOR ASPECT OF THE RIGHT S1 LATERAL RECESS. CORRELATION WITH ANY SYMPTOMS OF RIGHT S1 RADICULOPATHY WAS RECOMMENDED. ON (B)(6) 2007 PATIENT UNDERWENT MRI SCAN DUE TO SOME OVERHANG OF THE L5-S1 FACETS OVER THE S1 NERVES. ON (B)(6) 2007 PATIENT PRESENTED DUE TO LEFT GROIN PAIN. IMPRESSION: POST-SURGICAL CHANGES IN THE LOWER LUMBAR SPINE. NO PLANE FILMS OF THE PELVIS AND LEFT HIP. ON (B)(6) 2007 PATIENT PRESENTED DUE TO SPINE, NERVE ROOT BLOCK 1 VIEW DUE TO LEG AND PERONEAL PAIN. ON (B)(6)2007 PATIENT UNDERWENT CT SCAN DUE TO ENCROACHMENT UPON THE S1 NERVE. ON (B)(6) 2007 PATIENT PRESENTED FOR AN OFFICE VISIT. ON (B)(6) 2007 PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO HER BILATERAL S1 DECOMPRESSION. ON (B)(6) 2007 PATIENT UNDERWENT LUMBAR DECOMPRESSION L5-S1 BILATERALLY DUE TO THE FOLLOWING PRE-OP DIAGNOSIS: LUMBOSACRAL FACET HYPERTROPHY, CAUSING SCIATICA BILATERALLY. IMPRESSION: HYPERTROPHIC CHANGE OF BILATERAL L5-S1 FACETS CAUSING S1 NERVE IMPINGEMENT. ON (B)(6) 2007, (B)(6) 2008 PATIENT PRESENTED FOR AN OFFICE VISIT. ON (B)(6) 2007 PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO LOW BACK PAIN. 05 DEC 2007 PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO PARASPINAL INJECTION. ON (B)(6) 2008 PATIENT PRESENTED DUE TO PAIN IN UPPER BACK, (B)(6) 2008 PATIENT PRESENTED DUE TO SPINE, NERVE ROOT BLOCK 1 VIEW DUE TO PERSISTENT INNER LEG AND -PERINEAL PAIN, POST L4-5, L5-S1 FUSION. ON (B)(6) 2008 PATIENT UNDERWENT MRI OF LUMBAR SPINE WITH AND WITHOUT GADOLINIUM. IMPRESSION: POSTOPERATIVE LUMBAR SPINE. SCREW AND PLATE FIXATION INVOLVING L4, L5 AND S1 VERTEBRAL BODIES, STATUS POST LEFT L4-L5 LAMINECTOMY, (B)(6) 2008 PATIENT PRESENTED FOR AN OFFICE VISIT WITH MRI OF SACRAL CANAL, WHICH DOES NOT SHOW ANY STRUCTURE PUSHING ON THE S2 NERVES. ON (B)(6) 2008 PATIENT UNDERWENT X-RAY OF THE SI JOINT DUE TO PAIN. CONCLUSION: SLIGHT LEVOCONVEXITY OF THE LUMBAR SPINE WITH FUSION PLATES AT L5 AND L5-S1, WHICH APPEAR INTACT. MINIMAL DEGENERATIVE CHANGE AT LEFT SI JOINT. PATIENT UNDERWENT X-RAY OF THE STANDING PA PELVIC X-RAY DUE TO PAIN AND LEG LENGTH DISCREPANCY. ON (B)(6) 2010 PATIENT UNDERWENT MRI OF LUMBAR SPINE, WITHOUT AND WITH CONTRAST DUE TO PAIN IN MILD AND LOWER BACK. IMPRESSION: STRESS REACTION INVOLVING THE POSTERIOR ELEMENTS OF L2 AND L3, WHICH MIGHT BE CHRONIC IN NATURE AND RELATED TO CHRONIC FACET ARTHROPATHY, STRESS REACTION FROM ACUTE INJURY COULD MANIFEST IN THIS FASHION. THERE WAS HOWEVER NO DISPLAYED FRACTURE, NO STRESS REACTION WITHIN VERTEBRAL BODIES. POSTOPERATIVE CHANGES OF THE LOWER LUMBAR SPINE. ON (B)(6) 2010 PATIENT UNDERWENT MRI OF THORACIC SPINE WITHOUT CONTRAST. IMPRESSION: MILD INTERVERTEBRAL DISC DEGENERATIVE CHANGE, WITHOUT EVIDENCE OF FOCAL DISC HERNIATION OR STENOSIS. NO ACUTE THORACIC SPINE INJURY. ON (B)(6) 2006 PATIENT UNDERWENT THREE VIEWS OF THE LUMBAR SPINE AP AND LATERAL. ON (B)(6) 2006 PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO UNENHANCED CT OF THE LUMBAR SPINE. ON (B)(6) 2006 PATIENT UNDERWENT CT GUIDED LEFT SACROILIAC JOINT ARTHROGRAM DUE TO PERSISTENT BACK PAIN, POST LOWER SPINAL FUSION. ON 6(B)(6) 2007 PATIENT UNDERWENT SPINE, NERVE ROOT BLOCK, 1 VIEW DUE TO POST LOWER LUMBAR FUSION, PERSISTENT LEFT LEG PAIN. PROBABLE SACROILIAC JOINT DISEASE BUT ALSO SUSPICIOUS FOR S1 NERVE IRRITATION FROM RESIDUAL DISC OF L5-S1 LEVEL. ON (B)(6) 2007 PATIENT UNDERWENT MRI OF SPINE LUMBAR WITH/WITHOUT CONTRAST DUE TO LOW BACK PAIN RADIATING INTO LEGS. IMPRESSION: PATIENT DOES NOT HAVE TRANSITIONAL ANATOMY. NUMBERING UTILIZED FOR THIS EXAM ASSUMED THE HARDWARE TO BE AT L4-5 AND L5-S1. PATIENT WAS STATUS POST LEFT HEMILAMINECTOMY AT L4-5. CORRELATION WITH CT OR PLAIN FILM WOULD BE BETTER ABLE TO EVALUATE HARDWARE AND STATUS OF FUSION. THERE WAS NO CANAL STENOSIS OR NEURAL FORAMINAL NARROWING. THERE WAS A TINY LEFT FORAMINAL DISC PROTRUSION AT L2-3. CORRELATION WITH ANY SYMPTOMS OF LEFT L2 RADICULOPATHY WAS RECOMMENDED. MILD LATERAL RECESS STENOSIS FOR EACH S1 ROOT, PRIMARILY RELATED TO OSTEOPHYTES FROM THE ADJACENT FACET JOINT. CORRELATION WITH ANY S1 RADICULOPATHY WAS RECOMMENDED, TINY, 4MM, CYST IN THE ANTERIOR ASPECT OF THE RIGHT S1 LATERAL RECESS. CORRELATION WITH ANY SYMPTOMS OF RIGHT S1 RADICULOPATHY WAS RECOMMENDED. ON (B)(6) 2007 PATIENT UNDERWENT A SINGLE AP VIEW OF PELVIS DUE TO LEFT GROIN PAIN. ON (B)(6) 2007 PATIENT UNDERWENT SPINE, NERVE ROOT BLOCK, 1 VIEW DUE TO LEG AND PERONEAL PAIN. ON (B)(6) 2007 PATIENT UNDERWENT RADIOLOGICAL PROCEDURE OF CHEST PA AND LATERAL DUE TO PRE-OP EXAM FOR BACK SURGERY. ON (B)(6) 2007 PATIENT PRESENTED DUE TO LUMBAR DECOMPRESSION L5-S1 BILATERALLY. ON (B)(6) 2008 PATIENT PRESENTED DUE TO PERSISTENT INNER LEG AND PERINEAL PAIN. POST L4-5, CONSENT WAS OBTAINED WITH THE RISK OF NERVE DAMAGE EXPLAINED. ON (B)(6) 2008 PATIENT PRESENTED DUE TO BILATERAL DIGITAL MAMMOGRAPHY SCREENING. ON (B)(6) 2011 PATIENT UNDERWENT A RADIOGRAPHIC EXAM DUE TO LOW BACK PAIN. IMPRESSION: POSTSURGICAL CHANGES IN THE LOWER LUMBAR AND L5-S1 REGIONS. SACRUM, OTHERWISE, APPEARS NORMAL. ON (B)(6) 2013 PATIENT UNDERWENT MRI OF THE LUMBAR SPINE WITH AND WITHOUT CONTRAST DUE TO BACK AND LEFT LEG PAIN. IMPRESSION: POSTOPERATIVE CHANGES AS DESCRIBED AS WELL AS MILDLY BULGING ANNULI WITHOUT STENOSIS AT L2/L3 AND L3/L4. MILD DIFFUSE FACT HYPERTROPHY.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A L4 TO S1 FUSION PROCEDURE USING RHBMP-2/ACS ON (B)(6) 2006. PATIENT'S POST-OPERATIVE PERIOD HAS BEEN MARKED BY INCREASINGLY SEVERE LOWER BACK PAIN THAT RADIATES INTO HER LOWER EXTREMITIES. IT WAS REPORTED THAT AN MRI SCAN PERFORMED ON (B)(6) 2007, REVEALS NEUROCOMPRESSIVE LESIONS THAT ENCROACH ON HER S1 NERVE ROOT AT THE IMPLANT SITE. ON (B)(6) 2007, THE PATIENT UNDERWENT A DECOMPRESSIVE REVISION SURGERY AT THE IMPLANT SITE. IT WAS REPORTED THAT THE PATIENT CONTINUES TO EXPERIENCE SEVERE AND UNRELENTING LOWER BACK PAIN THAT RADIATES TO HER LOWER EXTREMITIES AND IS ACCOMPANIED BY NUMBNESS IN HER FEET.
(B)(6) 2006: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: LOW BACK AND LEFT BUTTOCK PAIN. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR LUMBAR INTERBODY SPINAL FUSION, L4-5, LS-81, USING FEMORAL RING ALLOGRAFT, BMP (BONE MORPHOGENIC PROTEIN), AND TENSION BAND PLATES. AS PER OPERATIVE NOTES, ¿AN 11 MM FEMORAL RING, WHICH HAD BEEN ESPECIALLY MACHINED AND PREPARED, WAS BROUGHT ONTO THE FIELD AND FILLED WITH BMP SPONGE.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. (B)(6) 2006: THE PATIENT WAS DISCHARGED FROM THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370490 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M115010AAI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |