BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN:C2 ANTERIOR FIXATION LOCKING PLATE

    MDR report key: 2992926 · Received February 28, 2013

    Report

    Report Number
    3006404071-2013-00002
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 28, 2013
    Manufacturer
    SPINESMITH HOLDINGS, LLC.
    Product Code
    OVE
    PMA / PMN Number
    K122360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DIMENSIONAL DISCREPANCIES WERE IDENTIFIED AND ALL MATERIAL AND PROCESSING CERTIFICATIONS WERE TO SPECIFICATION. VISUAL EVAL OF THE RETURNED SCREW USING MAGNIFICATION INDICATED THAT THE HEAD RECEIVED EXCESSIVE TORQUE WHICH LED TO THE SCREW FAILURE. TESTING HAS SHOWN THAT THE TORQUE REQUIRED TO DEPLOY THE LOCKING PLATE AS DESCRIBED IN THE SYSTEM SURGICAL TECHNIQUE IS NOT SUFFICIENT TO DAMAGE THE SCREW IN THE MANNER OBSERVED. THE REASON FOR THE EXCESSIVE TORQUE IS NOT KNOWN.

    Description of Event or Problem · 1

    WHILE FINAL TIGHTENING OF THE SET SCREW OF THE LOCKING PLATE, THE HEAD OF THE SCREW SHEARED OFF. ALL PIECES WERE REMOVED AND A DIFFERENT LOCKING PLATE WAS USED. THERE WAS NO DELAY OR SURGICAL IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87034 IN:C2 ANTERIOR FIXATION LOCKING PLATE IN:C2 SPINAL FIXATION SYSTEM OVE SPINESMITH HOLDINGS, LLC. 1104-0080 67AT

    Patients

    Seq Age Sex Outcome Treatment
    1