BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 4643638 · Received March 31, 2015

    Report

    Report Number
    1030489-2015-00676
    Event Type
    Malfunction
    Date Received
    March 31, 2015
    Date of Event
    March 3, 2015
    Report Date
    March 3, 2015
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 811-300, 510K # K982990 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE TO LENGTHEN THE RODS FOR TREATMENT OF SCOLIOSIS. IT WAS REPORTED THAT THE SET SCREW OF THE CONNECTOR STRIPPED. THE SURGEON DECIDED TO LEAVE THE SIDE UN-LENGTHENED AND COMPLETED THE PROCEDURE ON ANOTHER SIDE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210654 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00007 YR