BEUDAMED
    FDA Adverse Event Summary report: N

    55MM RT STANDARD MANDIBULAR

    MDR report key: 1842990 · Received September 23, 2010

    Report

    Report Number
    1032347-2010-00158
    Date Received
    September 23, 2010
    Date of Event
    July 13, 2010
    Report Date
    September 22, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION OF THE DEVICE NOT FUNCTIONING AS EXPECTED. PER THE DOCTOR, THE IMPLANTS WERE REMOVED DUE TO HETEROTOPIC BONE FORMATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT (HETEROTOPIC BONE FORMATION) CAN OCCUR. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. 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. THERE WERE 2 DEVICES IMPLANTED AND EXPLANTED, SEE MDR 1032347-2010-00159.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A RIGHT SIDE TMJ REPLACEMENT DONE IN (B)(6) 2006. DUE TO HETEROTOPIC BONE GROWTH, THE DOCTOR EXPLANTED THE ORIGINAL DEVICES, AND PLACED NEW DEVICES IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 55MM RT STANDARD MANDIBULAR TMJ DEVICE LZD BIOMET MICROFIXATION 980460

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization