BEUDAMED
    FDA Adverse Event Summary report: N

    TMJ SMALL RIGHT FOSSA

    MDR report key: 1631775 · Received March 16, 2010

    Report

    Report Number
    1032347-2010-00026
    Date Received
    March 16, 2010
    Date of Event
    January 12, 2010
    Report Date
    March 1, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. DOCTOR COMMENTED THE IMPLANTS WERE IN GOOD SHAPE, THE PATIENT JUST GREW HETEROTOPIC BONE AROUND THEM. 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. TWO IMPLANTS WERE REMOVED, SEE MDR 1032347-2010-00025.

    Additional Manufacturer Narrative · 1

    (B)(4). NO MODE OF FAILURE WAS IDENTIFIED FOR THIS DEVICE. CAUSE OF FAILURE: PRE-OP X-RAY AND INTRAOPERATIVE ASSESSMENT CONFIRMED THE PRESENCE OF BONE TISSUE ENCASING THE IMPLANT. DUE TO THESE OBSERVATIONS THE SURGEON DECIDED TO EXPLANT THE DEVICE. REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE 1032347-2010-00025-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REOCCURRENCE OF HETERTOPIC BONE THAT NECESSITATED A REVISION SURGERY TO REMOVE THE TMJ IMPLANTS (FOSSA AND MANDIBULAR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ SMALL RIGHT FOSSA TMJ LZD BIOMET MICROFIXATION 014100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization