BEUDAMED
    FDA Adverse Event Summary report: N

    45MM RIGHT STANDARD OFFSET TI MANDIBULAR

    MDR report key: 1890331 · Received November 3, 2010

    Report

    Report Number
    1032347-2010-00186
    Date Received
    November 3, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE IMPLANT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER, THE SURGEON CONFIRMED THAT THE TMJ DEVICE WAS NOT EXPLANTED DUE TO ITS FAILURE. THE SURGEON SUSPECTS THAT DESPITE THE FACT THAT THIS WAS THE SMALLEST STOCK IMPLANT, IT IS STILL JUST TOO LARGE FOR THIS PARTICULAR PATIENT. THE REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THIS LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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. THE IMPLANT WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT A BIOMET MICROFIXATION TMJ IMPLANT WAS EXPLANTED BECAUSE IT WAS NOT SMALL ENOUGH FOR THE PATIENT, AND A CUSTOM IMPLANT WAS REQUIRED. HOWEVER, THE SURGEON CONFIRMED THAT THE TMJ DEVICE IS NOT BEING EXPLANTED BECAUSE OF FAILURE OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM RIGHT STANDARD OFFSET TI MANDIBULAR TMJ LZD BIOMET MICROFIXATION 660830

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization