BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOCK SCR F/IMPL F/TRANSPALATAL DISTRACT

    MDR report key: 3132464 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02837
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    October 12, 2010
    Report Date
    April 19, 2011
    Manufacturer
    SYNTHES (USA) WEST CHESTER, PA
    Product Code
    MQN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA FEEDBACK TAKEN FROM A MARKET PREFERENCE EVALUATION FORM, THAT WHILE A PATIENT WAS BEING TREATED WITH A TRANSPLANT SYSTEM, A BLOCKING SCREW FELL OFF INTO THE PATIENTS MOUTH. THIS HAPPENED DURING THE SCREW INSERTION AND REMOVAL STEP USING THE DISTRACTOR. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237328 BLOCK SCR F/IMPL F/TRANSPALATAL DISTRACT MQN SYNTHES (USA) WEST CHESTER, PA

    Patients

    Seq Age Sex Outcome Treatment
    1