BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXILL-DISTRACTOR MAIN BODY MONOAX DISTR

    MDR report key: 2903532 · Received January 9, 2013

    Report

    Report Number
    2520274-2013-00169
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    January 15, 2009
    Report Date
    January 20, 2009
    Manufacturer
    SYNTHES
    Product Code
    JEY
    PMA / PMN Number
    NON-US
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE (B)(4) COMPLAINT HANDLING UNIT REPORTED THAT THE THREAD BROKE OFF. THE PLATE OF THE DISTRACTER WAS PRE BENT BEFORE SURGICAL OPERATION AND THE MOBILITY OF THE DISTRACTER WAS TESTED. THE PLATE WAS BENT TO ANATOMICAL SHAPE AND WHEN THE SURGEON TRIED TO CHECK THE MOBILITY OF THE EXTENSION, HE FELT RESISTANCE. HE CONTINUED TO EXTEND IT AND THE RESISTANCE DISAPPEARED. AFTER THIS HE TRIED TO CONTRACT AND THE RESISTANCE RETURNED. AS THE DISTRACTER DID NOT WORK WITH THE DRIVER, THE SURGEON REMOVED THE SCREWS AND ATTEMPTED TO CONTRACT THE DISTRACTOR MANUALLY AND IN SO DOING THE SHAFT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12656 MAXILL-DISTRACTOR MAIN BODY MONOAX DISTR MAXILLARY DISTRACTOR JEY SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1