BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATOR #301

    MDR report key: 1651382 · Received April 1, 2010

    Report

    Report Number
    9610905-2010-00009
    Event Type
    Injury
    Date Received
    April 1, 2010
    Date of Event
    March 15, 2010
    Report Date
    March 18, 2010
    Manufacturer
    KARL LEIBINGER GMBH U. CO. KG
    Product Code
    EMJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ELEVATOR HAS BEEN RETURNED AND FORWARDED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    DR (B) (6) REMOVED A 3RD MOLAR FROM PATIENT ON (B) (6) 2010. DR (B) (6) PERFORMED A POST-OP X-RAY ON PATIENT AND NOTICED A SMALL SLIVER OF METAL FROM A ELEVATOR INSTRUMENT USED IN SURGERY. DR (B) (6) REMOVED THE METAL FROM PATIENT ON (B) (6) 2010. PATIENT WAS NOT INJURED AND THE PATIENT'S LONG TERM HEALTH WAS NOT COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVATOR #301 ELEVATOR EMJ KARL LEIBINGER GMBH U. CO. KG 42-301-00 3C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other