BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 2410514 · Received January 11, 2012

    Report

    Report Number
    1030489-2012-00025
    Event Type
    Injury
    Date Received
    January 11, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 12, 2011
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 828-083, 510K # K880215 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: MULTIPLE AP AND LATERAL X-RAYS OF THORACOLUMBAR AND LUMBAR SPINE. SUBLAMINAR WIRES FROM PREVIOUS FUSION NOTED THROUGH MID-THORACIC SPINE WITH RODS REMOVED. NEW CONSTRUCT WITH PEDICLE SCREWS AT T9-T10-T11-T12-L3-L4 AND HOOKS BELOW L4. LONG SPAN AT CROSSLINK ABOVE L3 NOTED TO HAVE BROKEN ROD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FIXATION SURGICAL PROCEDURE AT T9-L4 WITH BONE GRAFTING VIA ANTERIOR APPROACH. IT WAS REPORTED THAT THE LEFT ROD BROKE AROUND L2 AND NON-UNION WAS CONFIRMED. THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH SOME OF THE SCREWS WERE REPLACED AND THE FIXATION LEVEL WAS EXTENDED TO T6. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS G828H083 0130455W

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWS