BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2904769 · Received January 9, 2013

    Report

    Report Number
    1030489-2013-00096
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 11, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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. 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-S1 POSTERIOR FUSION WITH L5-S1 PLIF USING RHBMP-2/ACS, INTERBODY DEVICES AND POSTERIOR INSTRUMENTATION TO TREAT DEGENERATIVE DISC DISEASE. APPROXIMATELY 2 MONTHS POST-OP, THE PATIENT DEVELOPED LEG PAIN, RADICULOPATHY AND POSTERIOR MIGRATION OF THE INTERBODY DEVICES. THE PATIENT UNDERWENT A REVISION SURGERY CONSISTING OF L5-S1 ALIF AND L3-PELVIS PSF. THE INSTRUMENTATION WAS REMOVED AND REPLACED. CULTURES WERE TAKEN WITH NO EVIDENCE OF INFECTION. THE SURGEON WAS HAPPY WITH THE PATIENT'S CONDITION AFTER THE REVISION SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11112 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 Required Intervention