BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEQUENCE ANTERIOR CERVICAL PLATE

    MDR report key: 3004929 · Received February 13, 2013

    Report

    Report Number
    3006404071-2013-00001
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 18, 2010
    Report Date
    February 12, 2013
    Manufacturer
    SPINESMITH HOLDINGS LLC
    Product Code
    KWQ
    PMA / PMN Number
    K082821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF X-RAYS, DEVICE NOT AVAILABLE, CANNOT DETERMINE FAILURE MODE. REVIEW OF DEVICE RECORDS DID NOT INDICATE ANY DISCREPANCIES THAT WOULD HAVE LED TO THE EVENT. NO ADDITIONAL PARTS FORM THE AFFECTED LOTS WERE AVAILABLE FOR REVIEW. NO OTHER SIMILAR EVENTS WERE IDENTIFIED. THERE HAS BEEN NO REPORTS OF A REVISION SURGERY AND THE DEVICES ARE NOT AVAILABLE FOR REVIEW. EVALUATION OF PROVIDED X-RAYS CONFIRMS THAT THE SCREW AT C3 HAS BACKED OUT. ADDITIONAL REVIEW SUGGESTS THAT THE LOCKING PLATE IS NOT SEATED OVER THE SCREW HEAD POSITION. IT IS NOT KNOWN IF THE LOCKING PLATE WAS FULLY LOCKED INTRA-OPERATIVELY OR IT MOVED POST-OPERATIVELY, HOWEVER ALL OTHER PLATES ARE IN THEIR CORRECT LOCKED POSITIONS. NOTE: THE INFORMATION CONTAINED IN THIS VOLUNTARY REPORT TESTS 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

    IT WAS NOTED ON (B)(6) 2010 THAT ONE OF THE SCREWS IN C3 IN A 2 LEVEL ACDF, C3-C5 HAS BACKED OUT. THE OTHER SCREWS ARE STILL IN PLACE AND THERE ARE NO PLANS TO REVISE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63902 CEQUENCE ANTERIOR CERVICAL PLATE SPINAL FIXATION SYSTEM KWQ SPINESMITH HOLDINGS LLC 0202-0017 05AG

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR SEL-TAPPING SCREWS, (B)(4), LOT 35AG| SEMI-CONSTRAINED 4.0MM X14MM SELF DRILLING/