BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMMERLOCK

    MDR report key: 5868420 · Received August 11, 2016

    Report

    Report Number
    1649263-2016-00034
    Event Type
    Injury
    Date Received
    August 11, 2016
    Date of Event
    April 16, 2013
    Report Date
    August 2, 2016
    Manufacturer
    BIOMEDICAL ENTERPRISES, INC.
    Product Code
    HTY
    UDI-DI
    00810633020067
    PMA / PMN Number
    K091951
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO BME.

    Description of Event or Problem · 1

    PATIENT UNDERWENT HAMMERTOE CORRECTION PROCEDURE ON (B)(6) 2013, DURING INSERTION, IMPLANT LEG EXPANDED AND CRACKED THE CORTICAL WALL. THE DEVICE WAS REMOVED AND K-WIRE USED FOR FINAL FIXATION. IF ADDITIONAL INFORMATION PERTINENT TO THIS INCIDENT IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520355 HAMMERLOCK HTY, PIN, FIXATION, SMOOTH HTY BIOMEDICAL ENTERPRISES, INC. HLXS 00810633020067

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention