BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN UNIFLEX NAIL

    MDR report key: 3973810 · Received August 1, 2014

    Report

    Report Number
    0001825034-2014-06718
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWC
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 - UNKNOWN. DATE IMPLANTED - 2001. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HUMERAL NAIL FIXATION PROCEDURE IN 2001. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2014 DUE TO PAIN. THE SCREW WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451186 UNKNOWN UNIFLEX NAIL SCREW, FIXATION HWC BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R