BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1507142 · Received October 8, 2009

    Report

    Report Number
    1030489-2009-00917
    Event Type
    Malfunction
    Date Received
    October 8, 2009
    Report Date
    September 10, 2009
    Manufacturer
    WARSAW ORTHOPAEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE SCREWS ASSOCIATED WITH THIS EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 8372545, 510K # K984522 WAS CLEARED IN THE UNITED STATES. MANUFACTURER DATE FOR LOT W07H4364 IS 09/17/2007; MANUFACTURER DATE FOR LOT 0032560W IS 06/05/2009. IMPLANTS REMAIN IMPLANTED, PRODUCT RETURN IS NOT POSSIBLE AT THIS TIME. X-RAY AND CT SCAN WITH MYELOPATHY PRE-OP AND POST-OP LUMBAR SPINE WITH DECOMPRESSIVE LAMINECTOMY AND POSTEROLATERAL FUSION AT L2-L3-L4 WITH POSTERIOR FIXATION. IT APPEARS THAT THE RIGHT L2 SCREW HAS LOOSENED AND BACKED OUT 10-15 MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLF AT L2/3/4 DUE TO STENOSIS TO IMPLANT POSTERIOR FIXATION. IT WAS REPORTED THAT THE POST OP CT SHOWED THE PEDICLE SCREW AT L2 BACKED OUT. THE PATIENT REPORTEDLY FELT DISCOMFORT DUE TO THE BACKED OUT PEDICLE SCREW. IT WAS REPORTED THAT THE PATIENT'S BONE WAS BRITTLE AND L2 PEDICLE HAD A FRACTURE PRIOR TO THE INDEX SURGERY. THERE IS NO REVISION SURGERY REPORTED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR (B) (4)| CATALOG #: G8372545, LOT# W07H4364