BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRAUMA

    MDR report key: 4821869 · Received June 5, 2015

    Report

    Report Number
    0001825034-2015-02434
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 15, 2015
    Report Date
    August 10, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSB
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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/LOT NUMBER - UNKNOWN; DATE IMPLANTED - UNKNOWN; INITIAL REPORTER - UNKNOWN; PMA/510(K) NUMBER ¿ UNKNOWN; MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ANKLE NAIL FIXATION PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2015 DUE TO FRACTURE OF THE NAIL AND NON-UNION OF THE PATIENT'S BONE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH SCREWS AND SURGICALLY IMPLANTED BONE GROWTH STIMULATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ANKLE NAIL PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE HAS BEEN INDICATED DUE TO FRACTURE; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365689 UNKNOWN TRAUMA NAIL, FIXATION HSB BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R