BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50MM LFT STANDARD OFF

    MDR report key: 2110097 · Received June 1, 2011

    Report

    Report Number
    1032347-2011-00077
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RETURN HAS BEEN REQUESTED, HOWEVER, THE PRODUCT HAS NOT BEEN RECEIVED BY MANUFACTURER. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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. SEE 1032347-2011-00079 AS TWO DEVICES WERE EXPLANTED FROM THE SAME PATIENT. OTHER: NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BI-LATERAL TMJ IMPLANTED (B)(6) 2010. THE PATIENT EXPERIENCED PAIN AND THE SURGEON EXPLANTED THE JOINT ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 50MM LFT STANDARD OFF TMJ LZD BIOMET MICROFIXATION 091260

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization