BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1070066 · Received July 3, 2008

    Report

    Report Number
    1030489-2008-00316
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Report Date
    June 5, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS REPORTED TO REMAIN IMPLANTED; THEREFORE, NO PRODUCT WILL BE RETURNED FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT SURGERY WITH IMPLANT OF RIGID POSTERIOR FIXATION. NO INTERBODY DEVICES WERE IMPLANTED. IT WAS REPORTED THAT THE PT HAD A POST-OP BONE SCREW BREAKAGE IN THE SACRUM. NO REVISION SURGERY IS PLANNED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM SCREW KWP WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK