BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3180670 · Received June 20, 2013

    Report

    Report Number
    1030489-2013-02440
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    August 15, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR L3-L5 TLIF WHERE RHBMP-2 WAS IMPLANTED WITH INTERBODY SPACERS, AUTOGRAFT, ALLOGRAFT, AND DBM PUTTY. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2007: THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: IRRIGATION AND DEBRIDEMENT OF LEFT FLANK STIMULATOR SITE. REMOVAL OF SPINAL CORD STIMULATOR LEADS AND BATTERY. L3-4 MAJOR DISCECTOMY WITH LAMINOFORAMINOTOMY. 4. L4-5 MAJOR DISCECTOMY WITH REVISION LAMINECTOMY. L3-4 AND L4-5 POSTERIOR INTERIOR-BODY ARTHRODESIS. L3-4 AND L4-5 INSERTION OF INTER-VERTEBRAL DEVICE. L3-4 AND L4-5 POSTEROLATERAL FUSION. L5-S1 REVISION POSTEROLATERAL FUSION. L3-4 NON-SEGMENTAL PEDICLE SCREW INSTRUMENTATION. L5 RE-INSERTION OF SPINAL FUSION. L5-S1 EXPLORATION OF SPINAL FUSION. MAJOR LEFT ILIAC CREST STRUCTURAL AUTOGRAFT HARVEST. MORCELLIZED ILIAC CREST BONE GRAFT. AS PER-OP NOTES, "AT L3-4, CANCELLOUS AUTOGRAFT WAS PACKED IN THE ANTERIOR DISK SPACE FOLLOWED BY A HALF STRIP OF BMP FOLLOWED BY PLACEMENT OF INTER-VERTEBRAL GRAFT AFTER ADEQUATELY HYDRATING IT FOR APPROPRIATE TIME. THIS WAS PERFORMED IN THE EXACT MANNER AT L4-5. THE CANCELLOUS AUTOGRAFT WAS SUBSEQUENTLY PLACED WITHIN THE INTERVAL IN THE LATERAL GUTTER BETWEEN THE L3 TRANSVERSE PROCESS AND THE LATERAL FUSION MASS AT L5-S1. THIS WAS FOLLOWED BY PLACEMENT OF CORTICAL CANCELLOUS STRIP, BMP AND DPM PUTTY AND CANCELLOUS MIXTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280583 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention