BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2863478 · Received December 10, 2012

    Report

    Report Number
    1030489-2012-02726
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    February 29, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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 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 ON (B)(6) 2007 PATIENT UNDERWENT THE FOLLOWING PROCEDURES: L3-L4 AND L4-L5 ANTERIOR LUMBAR INTERBODY FUSION. L3-L4 AND L4-L5 DEPUY AEGIS PLATING. L3-L4 AND L4-L5, PLACEMENT OF DEPUY COUGAR CAGES, ALLOGRAFT BONE GRAFT. PLACEMENT OF BONE MORPHOGENIC PROTEIN. PRE-OPERATIVE/ POST-OPERATIVE DIAGNOSES: L3-L4 AND L4-L5 ANNULAR TEARS WITH DISK PROTRUSION AND INSTABILITY. AS PER OP-NOTES: "...PROTRUDING DISC MATERIAL WAS EXCISED. THE DISC SPACE WAS SHAPED AND FITTED TO A SIZE 16 10-DEGREE COUGAR CARBON FIBER CAGE THAT HAD BEEN FILLED WITH LARGE BONE MORPHOGENIC PROTEIN KIT SATURATED INTO THE SPONGES PER THE MANUFACTURER'S RECOMMENDATION..." NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110608AAI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R