BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3201262 · Received July 2, 2013

    Report

    Report Number
    1030489-2013-02877
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 2, 2004
    Report Date
    April 16, 2018
    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

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE USED 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. IMPLANTED: (B)(6) 2004. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES OR MEDICAL RECORDS 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 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

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: INSTABILITY, STATUS POST PREVIOUS FUSION. SHE UNDERWENT THE FOLLOWING PROCEDURES: HARDWARE REMOVAL INSTRUMENTATION L2-3; EXPLORATION OF FUSION L2-3; POSTERIOR SPINAL FUSION L3-4 (NEW LEVEL) (4) INSTRUMENTATION L3-4-5, LOCAL BONE AND BONE GRAFT IN WHICH RHBMP2/ACS WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301554 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 40 YR Other