BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANDIB-PL-2 W/CENT-SPACE 6HO L40 TI

    MDR report key: 2914608 · Received January 14, 2013

    Report

    Report Number
    2520274-2013-00324
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    October 14, 2010
    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 (B)(4) 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)(6) REPORTED THAT THE SCREW DOES NOT SIT FLUSH IN THE HOLE. WHEN USING THE PLUS DRIVE 2.0 EMERGENCY SCREW, THE 2.4 SCREW, WITH THE 2.0 MANDIBLE PLATES FROM THE COMPACT COMBI SETS, THE SCREW DOES NOT SIT FLUSH IN THE PLATE HOLE LIKE IT DOES FOR THE MIDFACE PLATES, IT SITS QUITE PROUD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20433 MANDIB-PL-2 W/CENT-SPACE 6HO L40 TI 2.0 MANDIBLE SCREW JEY SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1