BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5X5MM RAPIDFIRE SCREWS,5PK

    MDR report key: 3120002 · Received May 20, 2013

    Report

    Report Number
    0001032347-2013-00173
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    PK971870
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 REPORTED THAT THE COMPLAINT ITEM WAS DISCARDED DURING THE REVISION SURGERY AND THEREFORE NOT AVAILABLE FOR REVIEW BY THE MANUFACTURER. THE USER FACILITY REPORTS THAT THE REVISION WAS SUCCESSFUL AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION. 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

    THERE WAS A REVISION DUE TO A FOREIGN BODY INFLAMMATORY RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221951 1.5X5MM RAPIDFIRE SCREWS,5PK BONE SCREWS HWC BIOMET MICROFIXATION N/A 748740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization