BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN:C2 3.5MM DIAMETER DUAL LEAD SCREW

    MDR report key: 3099500 · Received May 2, 2013

    Report

    Report Number
    3006404071-2013-00006
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 25, 2013
    Report Date
    May 2, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISCREPANCIES OR DEFICIENCIES WERE IDENTIFIED WITH THE PRODUCT LABELING AND INSTRUCTIONS FOR USE. REVIEW OF THE DEVICE HISTORY RECORD DID NOT INDICATE ANY MATERIAL, PROCESSING OR DIMENSIONAL DISCREPANCIES. FROM THE PROVIDED X-RAYS, THE PLATE DID NOT APPEAR TO BE FULLY SEATED TO THE VERTEBRAL BODY AS PRESCRIBED IN THE SURGICAL TECHNIQUE. IT IS NOT KNOWN IF THE PLATE WAS FLUSH AT THE TIME OF IMPLANTATION BUT THE GAP PLUS AN EXTREME ANGLE AND STEP CREATED FROM THE GAP MOST LIKELY CREATED A STRESS POINT AND LEVER ARM LEADING TO SCREW FRACTURE. NO OTHER SYSTEM DEFICIENCIES, SYSTEM DISCREPANCIES OR USER/PATIENT FACTORS WERE IDENTIFIED. 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 REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING 3 MONTH FOLLOW UP, X-RAYS REVEALED SCREW BREAKAGE IN C5. THE PHYSICIAN DOES NOT PLAN TO REVISE AT THIS TIME AND REPORTS THAT THE PATIENT APPEARS TO BE DOING VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191633 IN:C2 3.5MM DIAMETER DUAL LEAD SCREW IN:C2 CERVICAL SYSTEM OVE SPINESMITH HOLDINGS, LLC 1107-3516 64AR

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK