BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E. WALKER 6MM RT MED FOSSA

    MDR report key: 2143302 · Received June 29, 2011

    Report

    Report Number
    1032347-2011-00093
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    November 2, 2010
    Report Date
    June 2, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE DOCTOR'S COMMENT, THERE WAS NOT AN ISSUE ON THE DEVICE NOT FUNCTIONING CORRECTLY, BUT THE ISSUE WAS THE SIZE OF IMPLANT SELECTED AND USED WAS TOO LARGE FOR THE PATIENT. 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. THE DOCTOR WHO IMPLANTED THE DEVICES IS NOT THE SAME DOCTOR WHO EXPLANTED. IMPLANTED BY: DR. (B)(6) AT (B)(6). EXPLANTED BY: DR. (B)(6). THERE WERE 4 DEVICES EXPLANTED, SEE MDRS 1032347-2011-00091 TO 00094.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BILATERAL TMJ REPLACEMENT ON (B)(6) 2009. THE DEVICES WERE EXPLANTED ON (B)(6) 2010 DUE TO THEM NOT FITTING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E. WALKER 6MM RT MED FOSSA TMJ LZD BIOMET MICROFIXATION 089540

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization