BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM IMF SCREW SELF-DRILLING 12MM

    MDR report key: 3011929 · Received March 19, 2013

    Report

    Report Number
    1719045-2013-00616
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    December 10, 2012
    Report Date
    February 25, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    DZL
    PMA / PMN Number
    K010527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    (B)(4) REPORT WAS RECEIVED CONTAINING THE FOLLOWING INFORMATION: IT IS REPORTED THAT ON (B)(6) 2012, PATIENT WITH A LEFT ANGLE AND RIGHT PARASYMPHYSEAL MANDIBLE FRACTURE WAS SENT TO OPERATING ROOM FOR OPEN REDUCTION INTERNAL FIXATION OF COMPLICATED MANDIBLE FRACTURE USING MULTIPLE APPROACHES. ONE OF THE INTERMAXILLARY FIXATION SCREWS BROKE FLUSH WITH THE MANDIBULAR CORTEX. THIS BROKEN SCREW, WITHOUT THE HEAD, WAS LEFT IN PLACE IN THE REGION OF THE RIGHT PARASYMPHYSEAL MANDIBLE FRACTURE. THIS INFORMATION WAS PREVIOUSLY SUBMITTED TO THE FDA, VIA VOLUNTARY MEDWATCH (B)(4). THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113252 2.0MM IMF SCREW SELF-DRILLING 12MM DZL SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1