BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2862607 · Received December 10, 2012

    Report

    Report Number
    1030489-2012-02717
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    January 24, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF IMAGING STUDIES FOUND AS FOLLOWS: (B)(6) 2011 MRI SACRUM SAGITTAL AND AXIAL VIEWS SHOW NO EVIDENCE OF CORTICAL DISRUPTION OR BONE MARROW EDEMA. SI JOINTS SHOW NO DEGENERATIVE CHANGES, LOWER LUMBAR VERTEBRAE AND DISC/SPINAL CANAL APPEAR NORMAL. ON (B)(6) 2011, MRI LUMBAR SAGITTAL AND AXIAL T1 AND T2 IMAGES OF LUMBAR SPINE APPEAR ESSENTIALLY NORMAL. MILD AND SYMMETRIC DESICCATION IS NOTED IN ALL DISCS, WITHOUT SIGNIFICANT BULGING. ON (B)(6) 2011, CT LUMBAR POST DISCOGRAM CT SCAN SHOWING CONTRAST IN THE L3, L4 AND L5 DISC SPACES. THE L5 DISC SPACE APPEARS TO HAVE A SMALL ANNULAR TEAR ON THE RIGHT, WITHOUT EXTRAVASATION OF CONTRAST. THERE IS A SMALL AMOUNT OF GAS WITHIN THE SPINAL CANAL. THE L4 DISC SPACE ALSO HAS SOME PERIPHERALIZATION OF CONTRAST ON THE LEFT WITH SPREAD OF THE CONTRAST OUT OF THE AREA OF THE NUCLEUS CONSISTENT WITH ANNULAR DEGRADATION. ON (B)(6) 2012, CT LUMBAR PATIENT HAS UNDERGONE AN INTERVAL TWO LEVEL TLIF L3-L4-L5. SCREWS ARE NONSEGMENTAL SPANNING THE L4 LEVEL. CAPSTONE SPACERS WERE PLACED FROM THE LEFT. SOLID FUSION APPEARS AT L3, PARTIAL FUSION AT L4. BONE RESORPTION IS SEEN IN THE VERTEBRAL BODIES POSTERIOR TO THE SPACER INVOLVING L4 AND L5. THESE AR EAS ARE MULTIPLE, EACH MEASURE ABOUT 6MM IN DIAMETER. THERE APPEARS TO BE NO HETEROTOPIC BONE OR NERVE COMPRESSION. SCREW AND SPACE POSITION APPEAR TO BE APPROPRIATE. THE DEVICE WAS NOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT L3-4, L4-5 360 FUSION USING POSTERIOR INSTRUMENTATION, INTERBODY IMPLANTS, RHBMP-2/ACS, AUTOGRAFT, AND COLLAGEN SPONGE. PER THE OPERATIVE NOTES, "I DID SPRAY THE BONE MARROW ASPIRATE UPON THE BMP HELISTAT COLLAGEN SPONGE AND AT THAT POINT I DID APPROPRIATE TRIAL AND SIZING OF THE INTERBODY SPACE. I UTILIZED THE LOCALLY HARVESTED AUTOGRAFT, CLEANED IT FREE OF ITS NON-BONY ELEMENT. THE COMBINATION OF THE BMP, THE LOCALLY HARVESTED AUTOGRAFT AND THE CAPSTONE BMP FILLED INTERBODY FILLED IMPLANT WAS THEN PLACED INTO THE L4-5 INTERBODY SPACE ... I DID PLACE A SMALL AMOUNT OF BMP IN THE POSTEROLATERAL GUTTER ... AT THAT POINT, AFTER THE L3-4 DISC SPACE HAD BEEN APPROPRIATELY PREPARED AND IRRIGATED, I OF COURSE PLACED THE BMP LOCALLY HARVESTED AUTOGRAFT, ... INTERBODY IMPLANT INTO THE DISC SPACE ITSELF." AT 162 DAYS POST-OP, THE PATIENT PRESENTED WITH LOW BACK PAIN. A CT SCAN OF THE LUMBAR SPINE INDICATED "SATISFACTORY FUSION FROM L3 TO L5 LEVEL. NO BONY FRACTURE OR SUBLUXATION. PROBABLE CALCIFIED LEIOMYOMA OF THE UTERUS." AT 169 DAYS POST-OP, THE PATIENT PRESENTED WITH BACK PAIN. PER THE PHYSICIAN'S NOTES, "SHE HAS HAD CONTINUED PAIN AND SYMPTOMS IN HER LEG ... I HAVE REVIEWED THE CT IN DETAIL AND I BELIEVE THE CT SHOWS SCAR TISSUE WITH SOME MILD ECTOPIC CALCIFICATION ON THE PREVIOUSLY OPERATED AREA SHOWING SOME NEURAL FORAMINAL STENOSIS DUE TO THESE TWO PARTICULAR FINDINGS ON THE PATIENT'S LEFT SIDE. THIS COULD EXPLAIN HER LOWER EXTREMITY RADICULOPATHY ON THE LEFT." AT 302 DAYS POST-OP, THE PATIENT UNDERWENT A LUMBAR FORAMINOTOMY AT L4, LEFT, AND EXPLORATION OF L3, LEFT. THE POST-OPERATIVE DIAGNOSIS WAS "STENOSIS AT L4 ON THE LEFT WITH JUST SCAR TISSUE AT L3 ON THE LEFT, STATUS POST LUMBAR FUSION AT L3-4 AND L4-5." PER THE OPERATIVE NOTES, "WE ... IDENTIFIED THE PEDICLE OF L5 ON THE LEFT AND THEN CAME OVER THE TOP OF IT AND INTO THE NEURAL FORAMEN ABOVE THE BONY MASS THAT WAS IN THE FORAMINAL PART OF THE CANAL. I COULD FREE THAT UP FROM SCAR AND THEN FIND THE INFERIOR PORTION OF THE L4 PEDICLE AS WELL. I THEN USED AN OSTEOTOMY PLACED AT THE LEVEL OF THE JUNCTION OF THE ECTOPIC BONE AND THE PEDICLE TO TAKE IT DOWN TO THE LEVEL OF THE DISK SPACE IN A HORIZONTAL FASHION AND THEN TURN THE OSTEOTOME 90 DEGREES AND THEN TOOK DOWN THE LARGE MASS FROM THE MEDIAL PORTION OF THE SPINAL CANAL ... I WAS ABLE TO GET DOWN TO THE RESIDUAL DISK SPACE INTO THE FLOOR OF THE CANAL AND IDENTIFY THE NERVE ROOT ENCASED SOMEWHAT IN SCAR. AFTER REMOVING THE MASS OF BONE PIECEMEAL, THE NERVE ROOT NO LONGER HAD A KNUCKLE UNDERNEATH IT FROM THE BONE ITSELF. I THEN TURNED MY ATTENTION TO THE L3 ON THE LEFT SIDE, I ENTERED THE FORAMINAL PART OF THE CANAL, THIS WAS MORE OF A SCAR TYPE ISSUE, THERE REALLY WASN'T ANY CALCIFICATION. WHAT I THOUGHT WOULD BE CALCIFIED WAS PROBABLY JUST AN ASYMMETRIC CUT OF THE L4 PEDICLE CRANIALLY. I COULD PASS A PROBE IN WITHOUT DIFFICULTY AND, AFTER EXPRESSION OF THE L3 SIDE, NO ADDITIONAL ATTENTION WAS REQUIRED... THERE WERE NO NOTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 54 YR Required Intervention