BEUDAMED
    FDA Adverse Event Summary report: N

    LEFT STANDARD MANDIBLE

    MDR report key: 1712917 · Received June 8, 2010

    Report

    Report Number
    1032347-2010-00098
    Date Received
    June 8, 2010
    Date of Event
    March 18, 2010
    Report Date
    May 11, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, THERE WAS NOT INDICATION OF PRODUCT MALFUNCTION FOR THE TMJ DEVICES. THEY WERE REPLACED DUE TO HETERTOPIC BONE GROWTH. THE EXPLANTED DEVICES WERE NOT RETURNED FOR REVIEW. 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 PATIENT HAS HAD 2 REVISION SURGERIES, SEE MDR 1032347-2010-00095 TO 00098

    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, WHICH WAS REPORTED AS EXPECTED TO THE PS 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. RECURRENT INFECTIONS DOCUMENTED. FISTULA WITH PUS DRAINAGE DESCRIBED BY SURGEON IN DIRECT COMMUNICATION WITH PROSTHETIC. CONFIRMED STAPHYLOCOCCUS AUREUS BY PATHOLOGY ANALYSIS. REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE 1032347-2010-00097-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD TMJ IMPLANTS PUT IN (B)(6) 2007, AND DUE TO HETERTOPIC BONE GROWTH, THEY WERE REMOVED (B)(6) 2007. THE PATIENT HAS SINCE HAD ANOTHER REVISION SURGERY, DUE TO HETERTOPIC BONE GROWTH, WHERE A 3RD SET OF TMJ IMPLANTS ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEFT STANDARD MANDIBLE TMJ LZD BIOMET MICROFIXATION 190960

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization