BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDIUM LEFT INVST FOSSA COMPONENT

    MDR report key: 1051793 · Received May 28, 2008

    Report

    Report Number
    1032347-2008-00022
    Event Type
    Other
    Date Received
    May 28, 2008
    Date of Event
    March 29, 2007
    Report Date
    May 19, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFO 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.

    Description of Event or Problem · 1

    RECEIVED NOTIFICATION FROM (B) (6), OF 01-6561 BEING EXPLANTED ON (B) (6) 2008. PER INFO RECEIVED FROM DR (B) (6), IT WAS REMOVED DUE TO INFECTION; AND THE COMPLICATIONS WAS NOT RELATED TO THE DEVICE; A TEMPORAL FLAP WAS USED TO FILL THE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIUM LEFT INVST FOSSA COMPONENT TMJ FOSSA LZD BIOMET MICROFIXATION 001840

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization WITH SCREWS TO HOLD THE IMPLANTS. NONE OF THE| OTHER 3 HAVE BEEN EXPLANTED.| THREE OTHER IMPLANTS WERE ALSO IMPLANTED, ALONG