INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-00267
- Event Type
- Injury
- Date Received
- January 28, 2013
- Report Date
- November 30, 2015
- 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)(6). (B)(4).
REVIEW OF RADIOGRAPHIC IMAGING STUDIES FOUND AS FOLLOWS: ON (B)(6) 2011 LUMBAR MRI L5/S1 RIGHT SIDED UNILATERAL PEDICLE SCREW CONSTRUCT WITH CAPSTONE. FLUID COLLECTION IS NOTED BEHIND THE CAGE. MILD DESICCATION IS NOTED AT DISC LEVELS ABOVE SURGERY. NO STENOSIS APPRECIATED. ON (B)(6) 2012 MRI LUMBAR NO INTERVAL CHANGE. CONTINUED FLUID DENSITY BEHIND SPACER WITHOUT NERVE COMPRESSION.
DATE OF SURGERY: (B)(6) 2011, PATIENT INITIALS: (B)(6). GENDER: FEMALE. AGE: (B)(6). TYPE OF PROCEDURE: POSTERIOR LUMBAR. IT WAS REPORTED THAT SOMETIME FOLLOWING SURGERY ON (B)(6) 2011 USING RHBMP-2/ACS, THE PATIENT ALLEGEDLY BEGAN TO EXPERIENCE MUSCLE CRAMPS AND SPASMS, SEVERE PAIN AND NUMBNESS IN RIGHT LEG AND FOOT, FLUID RETENTION, AND INABILITY TO STAND FOR LONG PERIODS OF TIME. (B)(6) 2011 - PT. UNDER SURGERY TO TREAT DEGENERATIVE DISC DISEASE WITH LUMBAR STENOSIS AT RIGHT L5-S1 DISC SPACE. PROCEDURE WAS FOR RIGHT L5 HEMILAMINOTOMY WITH TOTAL FACETECTOMY AND FORAMINOTOMY, RIGHT L5 DISCECTOMY, MINIMALLY INVASIVE TLIF L5-S1, POSTEROLATERAL FUSION L5-S1 WITH POSTERIOR SEGMENTAL FIXATION AT RIGHT L5-S1. A MIXTURE OF BMP SPONGE AND HARVESTED BONE GRAFT WAS PLACED IN THE DISC SPACE AND INSIDE THE INTERBODY CAGE. BONE GRAFT WAS USED FOR POSTEROLATERAL FUSION. (B)(6) 2011 - LUMBAR MRI. "NOTED POSTERIOR TO THE BONE GRAFT IS A FLUID-FILLED LEVEL WITHIN THE RIGHT POSTEROLATERAL ASPECT OF THE DISC SPACE OF L5/S1 AND ALSO APPEARING TO INVOLVE THE LATERAL RECESS AND FORAMEN. THIS OVERALL ABNORMALITY IS PARTLY OBSCURED BY METALLIC ARTIFACT, BUT HAS DIMENSIONS OF APPROXIMATELY 1.6 X 2 X 1 CENTIMETERS IN SIZE. THE LEFT FORAMEN IS PATENT. THE THECAL SAC IS NOT COMPROMISED".
IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSES: 1. DEGENERATIVE DISK DISEASE WITH LUMBAR STENOSIS AT RIGHT L5-S1 INTERSPACE. 2. TWO PREVIOUS LUMBAR DISKECTOMIES AT L5-S1 FROM THE RIGHT SIDE. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1. RIGHT L5 HEMILAMINECTOMY WITH TOTAT FACETECTOMY AND FORAMINOTOMY FOR DECOMPRESSION OF THE NERVE ROOT. 2. RIGHT L5-S1 DISKECTOMY. 3. POSTERIOR LUMBAR INTERBODY FUSION AT THE INTERSPACE OF L5-S1 USING MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION TECHNIQUE. 4. POSTEROLATERAL FUSION AT L5 AND S1. 5. POSTERIOR SEGMENTAL INSTRUMENTATION AT THE RIGHT L5 AND S1 USING PEDICLE SCREWS. 6. INSERTION OF INTERBODY CAGE MEASURING 10 BY 22MM. 7. MORCELIZED AUTOGRAFT. 8. MORCELIZED ALLOGRAFT USING BONE MORPHOGENIC PROTEIN. 9. MICROSURGICAL DISSECTIONS USING SURGICAL MICROSCOPE. PER OP NOTES: THE SURGEON WAS ABLE TO USE DIFFERENT CURETTES AND DISTRACTORS TO OPEN UP THE DISK SPACE AND PUSH DOWN THE DISK FRAGMENTS. THESE WERE REMOVED WITH THE PITUITARIES. THE SURGEON WAS THEN ABLE TO PASS A 10BY 22 MM INTERBODY CAGE INTO THE INTERSPACE. HE PLACED A MIXTURE OF BONE MORPHOGENIC PROTEIN SPONGE WITH HARVESTED BONE GRAFT INTO THE DISK SPACE FOLLOWED BY THE CAGE AND CAGE ALSO HAD A MIXTURE OF BONE MORPHOGENIC PROTEIN AND HARVESTED BONE GRAFT IN THE MIDDLE. ONCE, THE CAGE WAS IN, THE LOCATION WAS VERIFIED ON C-ARM FLUOROSCOPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37667 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | M111064AAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR | Other |