BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING RECONSTRUCTION PLATE 6X23 HOLES 44MM X 21

    MDR report key: 2359580 · Received September 30, 2011

    Report

    Report Number
    1719045-2011-00583
    Event Type
    Injury
    Date Received
    September 30, 2011
    Date of Event
    September 6, 2011
    Report Date
    September 6, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K961421
    Removal / Correction Number
    1719045-2011-00583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS IN THE EVAL PROCESS.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH A MANDIBULAR LOCKING RECONSTRUCTION PLATE IN DEC 2009. PLATE BROKE POST-OPERATIVELY. SURGEON EXPLANTED PLATE AND IMPLANTED ANOTHER LRP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING RECONSTRUCTION PLATE 6X23 HOLES 44MM X 21 LOCKING RECONSTRUCTION PLATE JEY SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention