BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3DX EXTERNAL MANDIBULAR DISTRACTOR

    MDR report key: 3057254 · Received April 10, 2013

    Report

    Report Number
    9610905-2013-00014
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 5, 2013
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH AND CO. KG
    Product Code
    MQN
    PMA / PMN Number
    K034027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON SELECTED TO REMOVE DEVICE EARLY BECAUSE HE DID NOT FEEL IT WAS FUNCTIONING CORRECTLY UNDER LOAD. SOME DISTRACTION WAS ACHIEVED. PATIENT HEALTH WAS NOT COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149722 3DX EXTERNAL MANDIBULAR DISTRACTOR MQN KARL LEIBINGER MEDIZINTECHNIK GMBH AND CO. KG 51-601-90 31967955

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other