BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PLATE

    MDR report key: 3946153 · Received July 21, 2014

    Report

    Report Number
    0001032347-2014-00209
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FILE 1 OF 2. PRODUCT RETURN REQUESTED BUT NOT YET RECEIVED. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE PART AND LOT HISTORY OF THE IMPLANTED UNIT IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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.

    Description of Event or Problem · 1

    THE PLATE IN THE PATIENT'S MOUTH BROKE ONE DAY POST-OPERATION. A REVISION HAS BEEN SCHEDULED. PRODUCT RETURN HAS BEEN REQUESTED AND IF RECEIVED, AN EVALUATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425056 UNKNOWN PLATE BONE PLATE HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization