BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODISC-L TRIAL-IMPL L 11 10

    MDR report key: 3183025 · Received June 21, 2013

    Report

    Report Number
    2530088-2013-00966
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    July 20, 2011
    Report Date
    July 25, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT. THE EVALUATION REVEALED THAT THE TRIAL INSTRUMENT HAS INDEED BROKEN APART. PLEASE NOTE THAT THIS IS AN OLD AND OFTEN USED INSTRUMENT OVER 10 YEARS AND IS CLEARLY VISIBLE. THEREFORE WE DO SUPPOSE THAT THE BREAKAGE WAS CAUSED DUE TO NORMAL WEAR AND TEAR OVER THE YEARS. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD OF THE TRIAL BROKE OFF. THE TRIAL WAS INSERTED INTO THE PATIENT FOR THE PURPOSE OF TRIALING FOR SIZE, WHEN THE HEAD OF THE TRIAL BROKE OFF THE STEM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283674 PRODISC-L TRIAL-IMPL L 11 10 MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1