BEUDAMED
    FDA Adverse Event Injury Summary report: N

    55MM RT STANDARD MAND

    MDR report key: 2010564 · Received March 8, 2011

    Report

    Report Number
    1032347-2011-00026
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    July 21, 2009
    Report Date
    February 15, 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

    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. THERE WERE 2 DEVICES IMPLANTED AND EXPLANTED TOGETHER, SEE MDR #1032347-2011-00025 ALSO. THE REPORTS 1032347-2011-00027 AND 00028 ARE ALSO FOR THE SAME PATIENT, BUT WITH DIFFERENT IMPLANT AND EXPLANT DATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD STOCK TMJ IMPLANTED ON (B)(6) 2007, AND IT WAS REMOVED ON (B)(6) 2009 BECAUSE THE PATIENT HAD PERCEIVED JOINT NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 55MM RT STANDARD MAND TMJ LZD BIOMET MICROFIXATION 047090

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization