BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ BONE SCREW

    MDR report key: 2925212 · Received January 22, 2013

    Report

    Report Number
    0001032347-2013-00018
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK953385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE WARNINGS IN THE PACKAGE INSERT STATE PROPER STERILIZATION TECHNIQUES THAT WHEN FOLLOWED WOULD PREVENT THIS TYPE OF DAMAGE. WITHOUT A KNOW LOT NUMBER, REVIEW OF THE MANUFACTURING RECORDS CANNOT BE PERFORMED. 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 DISTRIBUTOR REPORTED, PAINT CHIPPED OF THE SCREW DIAL LID AND THE PARTICLES STUCK ON THE SCREWS. THE SCREWS WERE THEN USED AND IMPLANTED INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30944 TMJ BONE SCREW BONE SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability