BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1590764 · Received January 28, 2010

    Report

    Report Number
    1030489-2010-00106
    Event Type
    Injury
    Date Received
    January 28, 2010
    Report Date
    December 30, 2009
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). LITERATURE ARTICLE CITATION: GOOD ET AL. CAN POSTERIOR-ONLY SURGERY PROVIDE SIMILAR RADIOGRAPHIC AND CLINICAL RESULTS AS COMBINED ANTERIOR (THORACOTOMY/THORACOABDOMINAL)/POSTERIOR APPROACHES FOR ADULT SCOLIOSIS'. SPINE 2010;35:210-218. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, WHO UNDERWENT A POSTERIOR SPINAL FUSION WITH RHBMP-2, SUFFERED RENAL FAILURE THAT REQUIRED HEMODIALYSIS AND RESPIRATORY FAILURE THAT REQUIRED 2 WEEKS OF VENTILATORY SUPPORT AND TRACHEOSTOMY POSTOPERATIVELY. AT THE FINAL FOLLOW UP, THE PATIENT HAD NORMAL RENAL AND PULMONARY FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT INFUSE BONE GRAFT NEK MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention