BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN:C2 ANTERIOR FIXATION LOCKING PLATE

    MDR report key: 3050265 · Received April 5, 2013

    Report

    Report Number
    3006404071-2013-00003
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    February 13, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SPINESMITH HOLDINGS, LLC
    Product Code
    OVE
    PMA / PMN Number
    K122630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DIMENSIONAL DISCREPANCIES WERE IDENTIFIED AND ALL MATERIAL AND PROCESSING SPECIFICATIONS WERE TO SPECIFICATION. VISUAL EVALUATION OF THE RETURNED SET SCREW USING MAGNIFICATION INDICATED THAT THE HEAD RECEIVED EXCESSIVE TORQUE WHICH LED TO THE FRACTURE OF THE SCREW HEAD AT THE BOTTOM OF THE INTERNAL DRIVER FEATURE. TESTING HAS SHOWN THAT THE TORQUE REQUIRED TO DEPLOY AND LOCK THE FINAL 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. NOTE: THE INFORMATION CONTAINED IN THIS REPORT REPRESENTS THE MOST COMPLETE AND UP TO DATE INFORMATION AVAILABLE. IT DOES NOT CONSTITUTE ANY ADMISSIONS, BUT PRESENTS THE RESULTS OF THE INVESTIGATION BASED ON THE INFORMATION AVAILABLE. THIS IS THE FINAL REPORT. SHOULD ANY ADDITIONAL DETAILS BECOME AVAILABLE THAT IMPACTS OR CHANGES THE INFORMATION CONTAINED IN THIS REPORT, A SUPPLEMENTAL REPOT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FINAL TIGHTENING OF THE LOCKING PLATE OF THE IN:C2 ANTERIOR FIXATION PLATE, THE TOP OF THE SET SCREW SHEARED OFF. ALL PIECES WERE REMOVED AND A DIFFERENT LOCKING PLATE WAS USED. THERE WAS NO DELAY OR MODIFICATION OF THE SURGICAL PROCEDURE AND NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141944 IN:C2 ANTERIOR FIXATION LOCKING PLATE IN:C2 SPINAL FIXATION SYSTEM OVE SPINESMITH HOLDINGS, LLC 1104-0070 66AT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK