BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACTOSORB1.5MM L SHAPE LEFT REG PLATE

    MDR report key: 3911982 · Received July 3, 2014

    Report

    Report Number
    0001032347-2014-00198
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK955729
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN REMOVED FROM THE PATIENT'S ANATOMY; THEREFORE, NO MANUFACTURER REVIEW IS POSSIBLE. 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.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTS A PATIENT EXPERIENCED SWELLING AND THE LACTOSORB SCREW CAME OUT OF THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389826 LACTOSORB1.5MM L SHAPE LEFT REG PLATE RESORBABLE BONE PLATE HRS BIOMET MICROFIXATION N/A 237670

    Patients

    Seq Age Sex Outcome Treatment
    1