BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRILL FREE MMF SCREW 2MM X 12MM

    MDR report key: 1631230 · Received March 12, 2010

    Report

    Report Number
    9610905-2010-00007
    Event Type
    Other
    Date Received
    March 12, 2010
    Date of Event
    February 22, 2010
    Report Date
    March 2, 2010
    Manufacturer
    KARL LEIBINGER GMBH U CO. KG
    Product Code
    DZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED; UNABLE TO FOLLOW-UP. NO EVALUATION OF PRODUCT CAN BE PERFORMED.

    Description of Event or Problem · 1

    DR. (B)(6) AT (B)(6) WAS PERFORMING AN OPERATION WHEN THE SCREW BROKE IN THE MANDIBLE (SYMPHYSIS REGION). THE THREAD PORTION OF THE SCREW HEAD WAS LEFT IN PATIENT (IDENTIFIER CW); THE HEAD OF THE SCREW WAS DISPOSED OF BY THE HOSPITAL. PATIENT'S LONG TERM HEALTH WAS NOT COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL FREE MMF SCREW 2MM X 12MM DRILL FREE SCREW DZL KARL LEIBINGER GMBH U CO. KG 25-098-08-1 803789

    Patients

    Seq Age Sex Outcome Treatment
    1 Other