BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING RECONSTRUCTION PLATE 6X23 HOLES 44MM X 21.

    MDR report key: 2274120 · Received September 28, 2011

    Report

    Report Number
    1719045-2011-00582
    Event Type
    Injury
    Date Received
    September 28, 2011
    Date of Event
    August 30, 2011
    Report Date
    September 1, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K961421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON-GOING. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT HAD A MANDIBULAR INFECTION WHICH RESULTED IN A BONY DEFECT. THE PLATE WAS IMPLANTED AND BROKE POST-OP. DATE OF FIRST PROCEDURE IS UNK. ON (B)(6), SURGEON IMPLANTED PT WITH A LOCKING 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 4845376

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention