BEUDAMED
    FDA Adverse Event Injury Summary report: N

    55MM LEFT STANDARD MANDIBLE

    MDR report key: 2181507 · Received July 27, 2011

    Report

    Report Number
    1032347-2011-00097
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, THERE WAS NO INDICATION THE DEVICE DID NOT FUNCTION AS EXPECTED. THE REVISION SURGERY WAS TO REMOVE THE EXCESSIVE HETEROTROPIC BONE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT 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. THERE WERE TWO DEVICES EXPLANTED, SEE MDR #1032347-2011-00098 ALSO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN ARTHOPLASTY PROCEDURE TO REMOVE EXCESSIVE HETERTROPIC BONE, WHICH RESULTED IN EXPLANTING HER TMJ DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 55MM LEFT STANDARD MANDIBLE TMJ LZD BIOMET MICROFIXATION 786510

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization