BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2830160 · Received November 13, 2012

    Report

    Report Number
    1030489-2012-02149
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    October 27, 2017
    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

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    REPORTEDLY THE PATIENT DEVELOPED "VERY SERIOUS PAIN AND A LIMITED MOBILITY. [THE PATIENT IS] WORRIED ABOUT THINGS GETTING WORSE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009: THE PATIENT WAS PREOPERATIVELY DIAGNOSED WITH LUMBAR STENOSIS AT L4-5 AND L5-S1 WITH SPONDYLOLISTHESIS AT L5-S1 AND UNDERWENT THE FOLLOWING PROCEDURES: PEDICLE SCREW FUSION, L4-5 AND L5-S1. PLACEMENT OF INTERBODY CAGES AT L4-5 AND L5-S1. TRANSVERSE PROCESS FUSION USING AUTOLOGOUS BONE, BONE GRAFT, INFUSED BMP. BILATERAL TOTAL FACETECTOMY AT L4-5 AND LS-S1 WITH FULL LAMINECTOMY FROM PARTIAL L4, FULL L5, PARTIAL S1. THE PATIENT UNDERWENT A MRI SCAN, PRIOR TO SURGERY REVEALED ADVANCED STENOSIS AT L5-S1 WITH A GRADE I SPONDYLOLISTHESIS WITH COMPRESSION OF THE L5 NERVE ROOTS AND THEIR FORAMINA AND AT L4-5. THERE WAS MODERATE LUMBAR STENOSIS BILATERALLY IN THE CENTRAL CANAL AND LATERAL RECESSES. THIS IS DUE TO A COMBINATION OF FACET HYPERTROPHY WITH LIGAMENTUM FLAVUM HYPERTROPHY AND DEGENERATIVE JOINT DISEASE. AS PER THE OP NOTES:¿ WE THEN PLACED OUR LEFT L4-5 SCREW FIRST PLACING THE AWL AND THEN THE PEDICLE PROBE, TESTING THE PROBE FOR IMPEDANCE AND THEN THE TAP OF 5.5 MM AND THE SCREW 6.5 MM. WE REPEATED THIS AT ALL 3 SEGMENTS ON BOTH SIDES. ONCE THE SCREWS WERE PLACED, WE DID A LAMINECTOMY WITH ASSORTED KNIVES, CURETTES, HOOKS AND RONGEURS. WHEN OUR LAMINECTOMY AND FACETECTOMY WAS DONE, WE EXPOSED THE L4-5 DISK AND ENTERED IT WITH A #15 BLADE AFTER COAGULATING BLEEDING POINTS WITH BIPOLAR AND THEN USING THE REAMERS AND CURETTES AND RONGEURS. I DID A RADICAL DISKECTOMY AND THEN PLACED FIRST THE 10 MM, THEN THE 12 MM TRIALER AND THEN THE 12 MM DEVICE WITH RH BMP-2/ACS. WE THEN PROCEEDED TO DO THE SAME THING AT THE LS-S1 LEVEL, PLACING THE CAGES FROM THE LEFT AT BOTH SEGMENTS. FINALLY, WE IRRIGATED 500 ML OF ANTIBIOTIC SOLUTION WITH PULSAVAC SYSTEM AND THEN PLACED THE BURRITOS OF RH BMP-2/ACS, BONE GRAFT AND AUTOLOGOUS BONE ACROSS THE TRANSVERSE PROCESS AND SACRUM, WHICH WAS PREPARED WITH A DRILL.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE 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 Other| R