BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SM LFT FOSSA COMP

    MDR report key: 1970178 · Received January 25, 2011

    Report

    Report Number
    1032347-2011-00010
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 4, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED AS PART OF THE (B)(6) STUDY. THIS IS LATE INFORMATION RECEIVED FROM THE (B)(6) STUDY (B)(6), WHICH WAS REPORTED AS EXPECTED TO THE (B)(6) STUDIES PROGRAM, BUT INADVERTENTLY NOT RECOGNIZED AS 803 REPORTABLE UNTIL AFTER THE CLOSE OF THE STUDY. NO MODE OF FAILURE WAS IDENTIFIED FOR THIS DEVICE. CAUSE OF FAILURE: INFECTION WAS DOCUMENTED AS THE REASON FOR EXPLANTATION. EVENT PROBLEM CODE, CONTACT OFFICE AND PHONE NUMBER, DATE RECEIVED BY MFR, DEVICE EVALUATED BY MFR?, AND EVALUATION CODES WERE UPDATED BASED ON THE RESULTS OF THE CLINICAL STUDY EXPLANT ANALYSIS. REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE 1032347-2011-00009-1.

    Additional Manufacturer Narrative · 1

    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. ALSO SEE 1032347-2011-00009 AS 2 DEVICES WERE EXPLANTED FROM THIS PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A BILATERAL TMJ REPLACEMENT ON (B)(6) 2008. THE PATIENT DEVELOPED AN INFECTION AND THE DOCTOR DECIDED TO REMOVE THE LEFT SIDE IMPLANTS ON (B)(6) 10. THE RIGHT SIDE ARE STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ SM LFT FOSSA COMP TMJ LZD BIOMET MICROFIXATION 212960

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization