BEUDAMED
    FDA Adverse Event Summary report: N

    MEDIUM LEFT INVEST FOSSA COMPONENT

    MDR report key: 1051798 · Received May 28, 2008

    Report

    Report Number
    1032347-2008-00018
    Date Received
    May 28, 2008
    Report Date
    May 2, 2008
    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

    CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADD'L 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. (B) (6). ALSO SEE 1032347-2008-00017, SAME CASE.

    Description of Event or Problem · 1

    PT HAD TMJ IMPLANTED ON (B) (6) 2000. OVER THE NEXT FIVE YRS, PT HAD PARTS OF THE TMJ IMPLANTED REMOVED DUE TO ALLERGIC REACTION. EXACT DATE OF EXPLANT UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIUM LEFT INVEST FOSSA COMPONENT FOSSA TMJ LZD BIOMET MICROFIXATION 095620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization (# OF SCREWS UNK)| 01-6556 ALSO IMPLANTED ALONG WITH SCREWS