BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN:C2 ANTERIOR FIXATION LOCKING PLATE 7MM

    MDR report key: 3237934 · Received July 17, 2013

    Report

    Report Number
    3006404071-2013-00008
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 21, 2013
    Report Date
    July 10, 2013
    Manufacturer
    SPINESMITH HOLDINGS, LLC
    Product Code
    OVE
    PMA / PMN Number
    K122630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISCREPANCIES DEFICIENCIES WERE IDENTIFIED AND ALL MATERIAL AND PROCESSING CERTIFICATIONS WERE TO SPECIFICATION. VISUAL EVALUATION 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 SCREWS IN THE MANNER OBSERVED. A COMPANY REPRESENTATIVE PRESENT IN THE OPERATING ROOM ADVISED THE PHYSICIAN NOT TO OVER-TIGHTEN PRIOR TO THE EVENT. THE REASON FOR THE EXCESSIVE TORQUE IS NOT KNOWN. NOTE: THE INFORMATION CONTAINED IN THIS VOLUNTARY REPORT REPRESENTS THE MOST COMPLETE AND 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 REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WHILE FINAL TIGHTENING OF THE ANTERIOR FIXATION LOCKING PLATE SET SCREW, 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
    330318 IN:C2 ANTERIOR FIXATION LOCKING PLATE 7MM IN:C2 SPINAL FIXATION SYSTEM OVE SPINESMITH HOLDINGS, LLC 1104-0070 66AT

    Patients

    Seq Age Sex Outcome Treatment
    1