BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 3061364 · Received April 16, 2013

    Report

    Report Number
    1030489-2013-01050
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: MACROSCOPIC AND OPTICAL EXAMINATION REVEALED THREAD CREST AND FLANK DAMAGE; THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD, AND IS CONSISTENT AROUND THE DAMAGED PORTION OF THE THREADS. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISALIGNMENT OF THE CONNECTOR AND SET SCREW THREADS DURING CONSTRUCT ASSEMBLY.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8281246, 510K # K011029 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 POSTERIOR LUMBAR INTERBODY FUSION AT L3-4 TO TREAT LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE SET SCREW COULD NOT BE BROKEN OFF IN THE BONE SCREW AFTER BEING CROSS THREADED. THE SET SCREW AND THE BONE SCREW WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162355 TSRH SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION MNI WARSAW ORTHOPEDICS NA 0232274W

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE SCREW