BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXILL-DISTRACTOR MAIN BODY MONOAX DISTR

    MDR report key: 3193269 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03713
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    April 5, 2012
    Report Date
    April 10, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K020505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE HOUSING OF THE DISTRACTOR BODY IS BROKEN AND THE THREADED SHAFT IS BADLY BENT. WE DO SUPPOSE THAT THESE DAMAGES WERE CAUSED DUE TO TOO MUCH MECHANICAL FORCE USING THE ALIGNMENT RODS. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTRACTORS WERE IMPLANTED ON THE LEFT AND RIGHT MAXILLA. ALIGNMENT RODS WERE APPLIED TO THE DISTRACTOR TO DETERMINE THE CORRECT VECTOR AND ONE OF THE DISTRACTORS SNAPPED. THERE WERE ONLY 2 X 25MM DISTRACTORS ON THE SET. THE SET WAS ORIGINALLY INCORRECTLY RESTOCKED WITH 4 X 15MM DISTRACTORS, AND NO 20MM DISTRACTORS. THEREFORE THE 25MM DISTRACTORS COULD ONLY BE CHANGED FOR A 15MM DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292573 MAXILL-DISTRACTOR MAIN BODY MONOAX DISTR JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR