BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY RETAINER

    MDR report key: 3003486 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10354
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE SAMPLE WAS RECEIVED WITH THE ARM BROKEN AROUND THE HINGE AREA. THE INSTRUMENT CORRESPONDS TO DRAWINGS AND PROCESSES PRIOR TO THE RELEASE OF AN UPDATED DESIGN. THE BREAK IS INDICATIVE OF TOO MUCH FORCE APPLIED DURING USAGE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT THEREFORE IS CONSIDERED INVALID FROM A MFG PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VERTEBRAL BODY RETAINER BROKE AS THE SURGEON WAS DISTRACTING VERTEBRAL BODY. ALL PIECES WERE RETRIEVED. ANOTHER RETAINER WAS SELECTED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87021 VERTEBRAL BODY RETAINER LXH SYNTHES GMBH A7QA50

    Patients

    Seq Age Sex Outcome Treatment
    1