BEUDAMED
    FDA Adverse Event Other Summary report: N

    2.0/0.6 2/2 HOLE RIGHT MED L PLATE

    MDR report key: 1172622 · Received September 10, 2008

    Report

    Report Number
    1032347-2008-00058
    Event Type
    Other
    Date Received
    September 10, 2008
    Date of Event
    May 20, 2008
    Report Date
    June 30, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K854886
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RETROSPECTIVE REVIEW OF FILE WAS PERFORMED ON (B) (6), 2008. NOTED THE MDR WAS NOT FILED IN THE 30 DAY TIME FRAME. 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. ALSO PLATE 01-8016 WAS IMPLANTED & EXPLANTED, SEE 1032347-2008-00034.

    Description of Event or Problem · 1

    PLATES AND SCREWS IMPLANTED IN MAXILLA IN (B) (6) 2007. PATIENT CAME IN FOR CHECK UP AT 3 MONTHS, DOCTOR NOTICED SOME MOVEMENT. AT 6 MONTH CHECK UP, TOOK X-RAYS, DETERMINED PLATE WAS BROKEN. REMOVED ON (B) (6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.0/0.6 2/2 HOLE RIGHT MED L PLATE BONE PLATE JEY BIOMET MICROFIXATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization SCREWS WERE USED, UNK HOW MANY & WHICH PART NUMBER