BEUDAMED
    FDA Adverse Event Other Summary report: N

    TMJ MED LEFT FOSSA COMP

    MDR report key: 1364011 · Received January 15, 2009

    Report

    Report Number
    1032347-2009-00001
    Event Type
    Other
    Date Received
    January 15, 2009
    Date of Event
    December 10, 2008
    Report Date
    December 11, 2008
    Manufacturer
    BIOMET MICROFIXATION, INC.
    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

    FROM WHAT WAS REPORTED, THE DOCTOR FOUND FOSSA SCREWS LOOSE ON ONE SIDE. THE DOCTOR HYPOTHESIZED THAT BECAUSE OF OVERLOADING, THE PT'S BITE WAS OFF SO, THE SCREWS BECAME LOOSE. WHEN EXPLANTED, VISUAL INSPECTION OF THE DEVICES SHOWED THEY WERE IN GOOD SHAPE, AND THERE WAS VIRTUALLY NO WEAR TO THE POLY. THEY WERE NOT RETURNED TO THE MFR BECAUSE THE PT IS (B) (6) POSITIVE. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADD'L INFO IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A F/U REPORT WILL BE SENT. SEE MDRS 1032347-2009-00001 TO 0004, AS ALL FOR SAME PT.

    Description of Event or Problem · 1

    BILATERAL TMJ FOSSA AND MANDIBULAR WERE IMPLANTED ABOUT 4 YRS AGO. ALL PIECES WERE EXPLANTED BECAUSE THE PT WAS EXPERIENCING PAIN AND EVENTUALLY A MALOCCLUSION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ MED LEFT FOSSA COMP TMJ LZD BIOMET MICROFIXATION, INC. 014090

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization PART NUMBER AND QTY OF SCREWS USED IN UNKNOWN.| SCREWS WERE USED TO FIXATE TO PATIENT.