BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANDIBULAR RECONSTRUCTION LOCKING PLATE

    MDR report key: 2142786 · Received April 13, 2011

    Report

    Report Number
    9610905-2011-00004
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 11, 2011
    Manufacturer
    KARL LEIBINGER GMBH U. CO. KG
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN OF PRODUCT FROM HEALTH CARE FACILITY. ONCE RECEIVED, IT WILL BE SENT TO THE MFR FOR EVAL.

    Description of Event or Problem · 1

    PLATE BROKE IN PT; REASON FOR BREAKAGE UNK. SURGERY WAS PERFORMED TO EXPLANT AND IMPLANT NEW PLATE ON (B)(6) 2011. PT'S LONG TERM HEALTH WAS NOT COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANDIBULAR RECONSTRUCTION LOCKING PLATE PLATE JEY KARL LEIBINGER GMBH U. CO. KG 50-771-26 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other