BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMANDIBLE 2X2 CRESCENT

    MDR report key: 1931592 · Received December 10, 2010

    Report

    Report Number
    3003506883-2010-00068
    Event Type
    Injury
    Date Received
    December 10, 2010
    Report Date
    November 1, 2010
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING, NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A TI MATRIXMANDIBLE 2 X 2 CRESCENT PLATE BROKE POST OPERATIVE. THE DOCTOR COMMENTED THAT THE PLATE WOULD HAVE BEEN BROKEN 2-3 MONTHS AFTER THE OPERATION. PROCEDURE: SSRO; SET BACK: 5-6 MM; GAP: 1.5 MM; ROTATION: 0.4 DEGREES. THERE IS NO GAP BETWEEN THE BUCCAL AND LINGUAL SIDE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI MATRIXMANDIBLE 2X2 CRESCENT TI MATRIXMANDIBLE CRESCENT PLATE JEY SYNTHES ELMIRA NA 5831027

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention SCREWS