BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3963765 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03329
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    July 25, 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. 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 A POSTEROLATERAL LUMBAR INTERBODY FUSION SURGERY USING RHBMP-2/ACS . AT AN UNKNOWN TIME POST-OP, IN 2007, THE PATIENT WAS DIAGNOSED WITH CHRONIC PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2007: PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: HERNIATED DISC. LUMBAR DISC DISEASE, STENOSIS. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: DECOMPRESSIVE LAMINECTOMY WITH BILATERAL DECOMPRESSIVE FORAMINOTOMIES, L4-S1. POSTERIOR LATERAL FUSION, L4-S1. SEGMENT INSTRUMENTATION, L4-S1 UNDER C-ARM CONTROL. BONE MORPHOGENIC PROTEIN, LOCAL BONE GRAFT. PER OP NOTES, BONE MORPHOGENIC PROTEIN ROLLED OVER BONE GRAFT WAS LAID INTO EACH GUTTER. REMAINING BONE GRAFTS WERE PACKED ON THE SIDE. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2007: PATIENT GOT DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440709 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 35 YR Other