BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5X4MM HT SD X-DR SCR, EA

    MDR report key: 3946196 · Received July 21, 2014

    Report

    Report Number
    0001032347-2014-00211
    Event Type
    Injury
    Date Received
    July 21, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK953385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR.THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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.FILE 2 OF 3.

    Description of Event or Problem · 1

    THE (B)(4) DISTRIBUTOR A PMMA REVISION SURGERY HAS BEEN SCHEDULED DUE TO PATIENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424469 1.5X4MM HT SD X-DR SCR, EA BONE SCREW JEY BIOMET MICROFIXATION N/A 960640

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization