BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFN LH 125 DEG 11MM X 340MM

    MDR report key: 3813341 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04058
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSB
    PMA / PMN Number
    PK100238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY WAS OUTSIDE OF THE UNITED STATES. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE & LOT NUMBER- UNKNOWN, DATE IMPLANTED - UNKNOWN, MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO A FRACTURED NAIL AND LOSS OF REDUCTION. THE AFFIXUS NAIL WAS REMOVED AND A LARGER AFFIXUS NAIL WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292011 HFN LH 125 DEG 11MM X 340MM ROD, FIXATION HSB BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R