BEUDAMED
    FDA Adverse Event Other Summary report: N

    5 X 22 LT LP ANGLE LOCKING MOD RECON PLATE

    MDR report key: 1006873 · Received February 26, 2008

    Report

    Report Number
    1032347-2008-00007
    Event Type
    Other
    Date Received
    February 26, 2008
    Date of Event
    November 21, 2007
    Report Date
    January 29, 2008
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Product Code
    HRS
    PMA / PMN Number
    K980512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR, IF A GRAFT IS NOT USED. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    MANDIBULAR PLATE IMPLANTED IN 2006 FOR A 60MM DEFECT RESECTION CASE, NO GRAFT WAS USED. PLATE FOUND BROKEN AND REMOVED IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 X 22 LT LP ANGLE LOCKING MOD RECON PLATE BONE PLATE HRS BIOMET MICROFIXATION, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization SCREWS WERE USED.| SCREWS WERE USED WITH THE PLATE