INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2014-02980
- Event Type
- Injury
- Date Received
- June 30, 2014
- Report Date
- September 28, 2015
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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.
(B)(4).
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SIGNIFICANT HISTORY OF LUMBAR AND CERVICAL DISC DISEASE AND INTRACTABLE PAIN. THE PATIENT HAD INTRACTABLE PAIN AND FAILURE OF NON-OPERATIVE CARE. ON (B)(6) /2006, THE PATIENT UNDERWENT C5-6 DISCECTOMY, ANTERIOR WITH DECOMPRESSION OF SPINAL CORD AND NERVE ROOTS, CERVICAL, SINGLE INTERSPACE; C5-6 ARTHRODESIS, ANTERIOR INTERBODY TECHNIQUE INCLUDING MINIMAL DISCECTOMY TO REPAIR INTERSPACE; BMP; OTHER THAN A CERVICAL DECOMPRESSION; C5-6 APPLICATION OF INTERVERTEBRAL BIOMECHANICAL DEVICE SYNTHETIC CAGE TO VERTEBRAL INTERSPACE; AND C5-6 ANTERIOR INSTRUMENTATION. ON (B)(6) 2006, THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS. ON (B)(6) 2006, THE PATIENT PRESENTS FOR A POST-OP EVALUATION. PATIENT REPORTS OCCASIONAL PAIN IN HIS NECK BUT RADICULAR SYMPTOMS HAVE RESOLVED. HAVING MORE TROUBLE WITH LOW BACK AND LEGS AND GETTING WORSE. TREATMENT INCLUDED FOLLOW UP IN (B)(6) 2007 WITH CERVICAL FILMS AND IF BACK WORSE, HE CAN FOLLOW UP EARLIER. ON (B)(6) 2006, THE PATIENT PRESENTS TO DISCUSS HIS BACK WHICH IS WORSE AND HAS MORE BACK AND LEG PAIN. TREATMENT INCLUDED CONSERVATIVE OPTIONS AT PAIN CLINIC. ON (B)(6) 2007, THE PATIENT PRESENTS WITH COMPLAINTS NECK PAIN WITH RIGHT UPPER EXTREMITY RADICULOPATHY FROM THE TRICEPS TO THE ELBOW; DAILY AND CONSTANT AND WAXES AND WANES; AND DESCRIBED AS ACHING, STABBING SENSATION, INCREASED WITH WORKING ON THE COMPUTER AND DECREASED WHEN IN A RECLINER. TREATMENT INCLUDED PERFORM A RIGHT OCCIPITAL NERVE BLOCK; TRIGGER POINT INJECTIONS ON THE RIGHT TRAPEZIUS MUSCLES; CONTINUE WITH MEDICATIONS; AND FOLLOW UP IN 2 WEEKS. ON (B)(6) 2007, THE PATIENT UNDERWENT A TRANSFORAMINAL L5 RIGHT SIDED EPIDURAL. ON (B)(6) 2007, THE PATIENT UNDERWENT RIGHT S1 TRANSFORAMINAL EPIDURAL AND RIGHT T11 PARAVERTEBRAL NERVE BLOCK. ON (B)(6) 2007, THE PATIENT UNDERWENT L4-5 BILATERAL HEMILAMINECTOMY WITH DECOMPRESSION OF NERVE ROOTS, INCLUDING MEDIAL FACETECTOMY, FORAMINOTOMY, AND EXCISION OF HERNIATED INTERVERTEBRAL DISK, ONE INTERSPACE, LUMBAR, BILATERAL, REEXPLORATION; L5-S1 EACH ADDITIONAL INTERSPACE, LUMBAR, BILATERAL, RE-EXPLORATION; L4-5 APPLICATION OF INTERVERTEBRAL BIOMEDICAL DEVICE, SYNTHETIC CAGE TO VERTEBRAL INTERSPACEL4-S1 POSTERIOR SEGMENTAL INSTRUMENTATION, PEDICLE SCREW FIXATION; L4 ARTHRODESIS, POSTEROLATERAL TECHNIQUE, SINGLE LEVEL, LUMBAR, WITH LATERAL TRANSVERSE TECHNIQUE; AND AUTOGRAFT FOR SPINE SURGERY, LOCAL LAMINAR HARVEST, OBTAINED FROM SAME INCISION. L4-S1 FRAGMENTS OF INTERVERTEBRAL DISC MATERIAL SAMPLES WERE SENT TO PATHOLOGY. ON (B)(6) 2007, THE PATIENT WAS DISCHARGED. ON (B)(6) 2007, THE PATIENT PRESENTED FOR POST OP EVALUATION. PATIENT WAS DOING WELL AND STARTED PT. TREATMENT INCLUDED WEAN OUT OF BRACE, CONTINUED PI AND FOLLOW UP IN 6 WEEKS WITH X-RAYS. ON (B)(6) 2007, THE PATIENT COMPLAINS OF CONTINUED PAIN ISSUES, BUT FEELS IMPROVEMENT IN HIS LEG SYMPTOMS. TREATMENT INCLUDED CONTINUED PT, SLOW INCREASE ACTIVITIES, AND TRYING TO WEAN HIS NARCOTICS. ON (B)(6) 2007, THE PATIENT UNDERWENT PLACEMENT OF EPIDURAL LEADS FOR PAIN STIMULATOR IN L3-4 AREA. ON (B)(6) 2007, THE PATIENT UNDERWENT A PLACEMENT OF SPINAL CORD STIMULATOR. ON (B)(6) 2008, PATIENT PRESENTED FOR FOLLOW UP POST STIMULATOR IMPLANTATION. STIMULATOR HAD DECREASED HIS PAIN AND REPORTED DECREASING HIS ORAL MEDICATION. TREATMENT FOLLOW UP IN FOR 1 YEAR LUMBAR X-RAY FILMS. ON (B)(6) 2008, THE PATIENT PRESENTS FOR 1 YEAR POST LUMBAR SURGERY. REPORTS HE IS BETTER AND HAPPY WITH THE RESULTS OF THE SURGERY. HAS PAIN BUT STIMULATOR HELPS. HIS NECK ALSO BOTHERS HIM AT TIMES. HE REMAINS IN SOME PAIN DAILY AND HAS TROUBLE SITTING FOR A LONG TIME. TREATMENT INCLUDED FOLLOW AS NEEDED. ON (B)(6) 2008, A CERVICAL SPINE CT SCAN WITHOUT CONTRAST REVEALED CHANGES OF PREVIOUS ANTERIOR FUSION AT C6-7 WITH ANTERIOR FIXATION PLATE AND SCREWS, AS WELL AS DISC SPACE GRAFT MATERIAL AND SOLID BONY FUSION; INTERVAL DEVELOPMENT OR PROGRESSION OF A CENTRAL DISC PROTRUSION AT C6-7 RESULTING IN MILD CENTRAL SPINAL CANAL STENOSIS; NO OTHER AREAS OF CENTRAL SPINAL CANAL STENOSIS OR NEUROFORAMINAL THROUGHOUT THE CERVICAL SPINE; AND EXOPHYTIC RIGHT THYROID NODULE. ON (B)(6) 2008, CERVICAL MYELOGRAM REVEALED CHANGES OF PREVIOUS FUSION WITH ANTERIOR FIXATION PLATE AND SCREWS PRESENT AT C5-6 WITH DISC SPACE GRAFT MATERIAL AND APPARENT SOLID FUSION ACROSS THE DISC SPACE LEVEL; NO FRACTURE, MALALIGNMENT OR ABNORMAL MOTION WITH FLEXION OR EXTENSION; SUBOPTIMAL OPACIFICATION OF THE CEREBRAL SPINAL FLUID CONTAINING SPACE WITH THE INTRATHECAL CONTRAST, NO DEFINITE EXTRADURAL DEFECTS ARE IDENTIFIED, AND THE POST MYELOGRAM CT SCAN HAS MUCH BETTER VISUALIZATION. ON (B)(6) 2008, THE PATIENT UNDERWENT RIGHT C6-7 TRANSFORAMINAL EPIDURAL STEROID INJECTION. ON (B)(6) 2008, THE PATIENT UNDERWENT RIGHT C7-T1 TRANSFORAMINAL EPIDURAL STEROID INJECTION FOR CERVICAL DISC DISEASE. ON (B)(6) 2009, THE PATIENT PRESENTS TO DISCUSS SURGERY. COMPLAINS OF DEBILITATING NECK PAIN WITH BILATERAL ARM RADIATION INTO BOTH HANDS WORSE ON LEFT WITH 3RD AND 4TH FINGERS AFFECTED. TREATMENT INCLUDED SCHEDULE REVISION ACDF. ON (B)(6) 2009, THE PATIENT UNDERWENT C5-6 REMOVAL OF ANTERIOR INSTRUMENTATION; C6-7 DISKECTOMY, ANTERIOR, WITH DECOMPRESSION OF SPINAL CORD AND NERVE ROOTS, CERVICAL, SINGLE INTERSPACE; C6-7 ARTHRODESIS, ANTERIOR INTERBODY TECHNIQUE, CERVICAL; C6-7 APPLICATION OF INTERVERTEBRAL BIOMECHANICAL DEVICE, SYNTHETIC CAGE, TO VERTEBRAL INTERSPACE; C6-7 ANTERIOR INSTRUMENTATION, SEPARATE AND DISTINCT PLATING AND SCREW SYSTEM AND SEPARATE LEVEL; AND AUTOGRAFT (BMP) FOR SPINE SURGERY, LOCAL HARVEST, OBTAINED FROM SAME INCISION. ON (B)(6) 2009, THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS. ON (B)(6) 2009, THE PATIENT PRESENTED FOR POST-OP VISIT. STILL HAS PAIN IN HIS RIGHT ARM AND SHOULDER WHICH HAD NOT IMPROVED SINCE SURGERY. TREATMENT INCLUDED FOLLOW UP 6 WEEKS WITH FILMS, RECONDITIONING PT AND WEAN OUT OF COLLAR. ON (B)(6) 2009, THE PATIENT PRESENTS FOR 12 WEEK POST OP EVALUATION. REPORTS NOT MUCH BETTER. HEADACHES ARE SOME BETTER BUT HIS ARM PAIN AND NUMBNESS ARE THE SAME. TREATMENT INCLUDED FOLLOW UP IN 3 MONTHS WITH FILMS AND INCREASE ACTIVITY AS TOLERATED. ON (B)(6) 2009, THE PATIENT PRESENTED WITH COMPLAINTS OF NO IMPROVEMENT POST SURGERY, CHANGE IN PAIN FROM 3RD AND 4TH FINGER TO HIS THUMB; CONTINUES TO HAVE NECK PAIN AND PAIN STARTING JUST BELOW HIS SHOULDER ON THE RIGHT ARM; AND LOW BACK IS ABOUT THE SAME. TREATMENT INCLUDED RUE EMG AND NERVE CONDUCTION. ON (B)(6) 2009, THE PATIENT UNDERWENT CERVICAL EPIDURAL STEROID INJECTION AND BILATERAL OCCIPITAL NERVE BLOCKS FOR FAILED CERVICAL NECK SYNDROME AND INTRACTABLE HEADACHES. ON (B)(6) 2010, CERVICAL CT SCAN WITHOUT CONTRAST REVEALED STATUS POST REVISION ANTERIOR DISCECTOMY AND CERVICAL FUSION WITH EXTENSION OF THE CERVICAL FUSION SPANNING THE C5 THROUGH C7 LEVELS. CONTIGUOUS INTERBODY FUSION IS PRESENT AT C5-6 WITH SPOT CONTIGUOUS INTERBODY FUSION AT THE LEVEL OF THE PEEK GRAFT AT C6-7, AS DESCRIBED. MILD RIGHT GREATER THAN LEFT NEUROFORAMINAL NARROWING IS PRESENT AT CG-7. ON (B)(6) 2011, THE PATIENT REQUESTED A SECOND OPINION ABOUT HIS HEADACHES WITH AURA LASTING ALL DAY, UNILATERAL, AND BEHIND THE RIGHT EYE. TREATMENT INCLUDED RECOMMENDATION TO SLOWLY LOWER HIS OPIOD DOSE. DIAGNOSED WITH DAILY HEADACHE, PROBABLE NARCOTIC REBOUND, SEVERE OPIOD DEPENDENCY, AND MIGRAINE WITH AURA.
IT WAS REPORTED THAT ON: (B)(6) 2006 PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: CERVICAL HERNIATED NUCLEUS PULPOSUS; CERVICAL STENOSIS; CERVICAL RADICULOPATHY; NECK PAIN. PROCEDURE: DISKECTOMY, ANTERIOR, WITH DECOMPRESSION OF SPINAL CORD AND NERVE ROOTS, CERVICAL, SINGLE INTERSPACE, C5-6; ARTHRODESIS, ANTERIOR INTERBODY TECHNIQUE, INCLUDING MINIMAL DISKECTOMY TO REPAIR INTERSPACE, OTHER THAN FOR DECOMPRESSION, CERVICAL, CS-6; APPLICATION OF INTERVERTEBRAL BIOMECHANICAL DEVICE, CAGE, TO VERTEBRAL INTERSPACE, C5-6; ANTERIOR INSTRUMENTATION. PER-OP NOTES: UNDER FLUOROSCOPIC GUIDANCE, THE DISK SPACE WAS SIZED TO AN 8-MM SIZE CAGE. THE INTERBODY SPREADERS WERE USED TO GAIN FULL ACCESS. THE ENDPLATE WAS THEN PREPARED WITH A HIGH-SPEED DRILL AND A CURVED CURETTE. AN 8-MM X 14-MM LORDOTIC CAGE WAS THEN BROUGHT ONTO THE FIELD AND PACKED WITH ONE-THIRD OF A SPONGE OF BONE MORPHOGENIC PROTEIN THAT HAD SOAKED FOR GREATER THAN 15 MINUTES. THE CAGE WAS GENTLY IMPACTED INTO THE SPACE AND APPROPRIATELY COUNTERSUNK. A FLUOROSCOPIC X-RAY SHOWED THE CAGE AT THE CORRECT POSITION AND AT THE RIGHT LEVEL. THIS COMPLETED PLACEMENT OF THE INTERVERTEBRAL BIOMECHANICAL DEVICE AND ARTHRODESIS. ON (B)(6) 2006, (B)(6) 2007 PATIENT PRESENTED FOR OFFICE VISIT WITH COMPLAINT OF PAIN. ON (B)(6) 2007 PATIENT PRESENTED WITH COMPLAINT OF LOW BACK PAIN AND NECK PAIN. ASSESSMENT: OCCIPITAL NEURALGIA; MUSCLE SPASMS/MYOFASCIAL DISEASE IN THE CERVICAL SPINE AND THE RIGHT TRAPEZIUS MUSCLES; RIGHT LOWER EXTREMITY RADICULOPATHY; STATUS POST ANTERIOR CERVICAL DECOMPRESSION AND FUSION; STATUS POST LUMBAR LAMINECTOMY AND DECOMPRESSION. ON (B)(6) 2007 PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: LUMBAR DISC DISEASE. ON (B)(6) 2007 PATIENT UNDERWENT FOLLOWING PRE-OP DIAGNOSIS: RIGHT LOWER EXTREMITY RADICULITIS; RIGHT T11 INTERCOSTAL NEURITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379522 | 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 |