BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSTIE

    MDR report key: 7457567 · Received April 24, 2018

    Report

    Report Number
    MW5076676
    Event Type
    Injury
    Date Received
    April 24, 2018
    Date of Event
    April 20, 2018
    Report Date
    April 23, 2018
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CROSSROAD IMPLANT BROKE DURING INSERTION DURING A BUNIONECTOMY PROCEDURE. DURING MANUAL INSERTION A PIECE BROKE OFF. THE IMPLANT WAS REMOVED AND NEW ONE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295967 CROSSTIE SCREW FIXATION BONE HWC CROSSROADS EXTREMITY SYSTEMS LLC 1443-2501 102861

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention