BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3170642 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02287
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    November 21, 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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 AN L5-S1 FUSION WITH RHBMP-2 AND PEEK CAGE. 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 PRESENTED WITH POST-LAMINECTOMY SYNDROME WITH LUMBAR PSEUDARTHRITIS AND UNDERWENT THE FOLLOWING PROCEDURES: REMOVAL OF POSTERIOR SEGMENTAL INSTRUMENTATION AND EXPLORATION OF L5-S1 FUSION; ANTERIOR APPROACH TO ANTERIOR LUMBAR INTERBODY ARTHRODESIS WITH INTERBODY CAGE WITH BONE MORPHOGENIC PROTEIN, WITH REMOVAL OF ANTERIOR HARDWARE AND EXPLORATION OF FUSION; POSTEROLATERAL ARTHRODESIS WITH PEDICLE SCREW INSTRUMENTATION. AS PER-OP NOTES, ¿A PEEK INTERBODY CAGE BY (B)(4), PACKED WITH COLLAGEN SPONGE APPROPRIATELY WAS PREPARED WITH BONE MORPHOGENIC PROTEIN. THIS WAS ALL DONE USING FLUOROSCOPIC CONTROL, AND GENTLY TAPPED INTO SECURE INTERBODY POSITION.¿ THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271581 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 00042 YR Required Intervention