BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSARM REMOVABLE FLEX L40 F/CMF DISTR

    MDR report key: 3173838 · Received June 17, 2013

    Report

    Report Number
    2939274-2013-00012
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    April 27, 2011
    Report Date
    May 23, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    PMA / PMN Number
    K080153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 EXTENSION ARMS WERE NOT USED ACCORDING TO THE OP-TECHNIQUE. BY TRYING TO PLACE THE EXTENSION ARMS INTRA-ORALLY FOR A RAMUS DISTRACTOR, THE ARMS GOT BENT BEYOND 180 DEGREES AND SNAPPED OFF FROM THE CHAIN LINKS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, THE EXTENSION ARMS BROKE. THE DISTRACTOR DEVICE WAS PLACED ON THE MANDIBULARY RAMUS SO THERE WAS VERY LITTLE SPACE TO PLACE EXTENSIONS ARMS INTRA-ORALLY. ALL PARTS WERE RETRIEVED AND RETURNED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272872 EXTENSARM REMOVABLE FLEX L40 F/CMF DISTR MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1