BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH® SPINAL SYSTEM

    MDR report key: 3067717 · Received April 19, 2013

    Report

    Report Number
    1030489-2013-01162
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8281248, 510K # K041282 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 REVISION SURGERY DUE TO SCREW LOOSENING. IT WAS REPORTED THAT THE SET SCREW SLIPPED DURING INSERTION IN THE BONE SCREW. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169282 TSRH® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR