BEUDAMED
    FDA Adverse Event Other Summary report: N

    45MM RIGHT NARROW MANDIBULAR

    MDR report key: 1172626 · Received September 10, 2008

    Report

    Report Number
    1032347-2008-00055
    Event Type
    Other
    Date Received
    September 10, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    P020016
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE INFORMATION REPORTED, THERE IS NO INDICATION THE PRODUCT FAILED TO PERFORM. 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. PATIENT ALSO HAD DEVICE IMPLANTED & REMOVED, SEE MDR 1032347-2008-00054.

    Description of Event or Problem · 1

    PRODUCT IMPLANTED IN 2006, REMOVED IN 2008, DUE TO PAIN BEING EXPERIENCED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM RIGHT NARROW MANDIBULAR TMJ HWC BIOMET MICROFIXATION 065140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization HOW MANY AND WHAT PART NUMBER OF SCREWS WERE USED.| SCREWS WOULD HAVE BEEN USED TO HOLD IMPLANT