BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM IMF SCREW SELF-DRILLING 12MM

    MDR report key: 2903462 · Received January 9, 2013

    Report

    Report Number
    1719045-2013-00063
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    DZL
    PMA / PMN Number
    K010527
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER

    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

    DURING A SURGERY ON (B)(6) 2012 FOR A MANDIBLE ANGLE FRACTURE, A SCREW BROKE DURING INSERTION. BOTH PIECES WERE RETRIEVED AND WILL BE DISCARDED. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10881 2.0MM IMF SCREW SELF-DRILLING 12MM 2.0MM IMF SCREW SELF-DRILLING 12MM DZL SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention