BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI ANTERIOR TENSION BAND PLATE

    MDR report key: 3042829 · Received February 26, 2013

    Report

    Report Number
    2530088-2013-10366
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    February 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    KWQ
    PMA / PMN Number
    K022791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. VISUAL EVAL NOTED ONE OF THE SCREW HOLES ON THE PLATE EXHIBITED EXTENSIVE SIGNS OF DAMAGE TO THE THREADS. IN ADDITION, DAMAGE TO A LESSER DEGREE, CONSISTENT WITH FIELD USAGE, WAS ALSO SEEN IN THE THREADS OF THE OTHER THREE HOLES. DUE TO THE DAMAGE EXHIBITED ON THE SCREW HOLES ON THE PLATE, EXACT MEASUREMENTS COULD NOT BE OBTAINED.

    Description of Event or Problem · 1

    DURING A PROCEDURE AT L5-S1, WHILE SURGEON WAS USING THE THREADED DRILL GUIDE (# (B)(4)) IN THE TI ANTERIOR TENSION BAND PLATE ((B)(4)) AND THE DRILL GUIDE SPLAYED OUT. THE CORRECT TRAJECTORY OF THE DRILL COULD NOT BE ACHIEVED AND THE SCREWS WOULD NOT LOCK ONTO THE PLATE. THE PLATE WAS REMOVED, SURGEON SELECTED ANOTHER PLATE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THIS FILE IS OPEN ON THE PLATE. THIS COMPLAINT IS 2 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83212 TI ANTERIOR TENSION BAND PLATE KWQ SYNTHES (USA) BRANDYWINE 5595189

    Patients

    Seq Age Sex Outcome Treatment
    1