BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BA-320-185

    MDR report key: 4102325 · Received August 27, 2014

    Report

    Report Number
    3005726841-2014-00007
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BIOTEX MEDICAL
    Product Code
    HOA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING COMPLETION OF PROCEDURE, IT WAS DISCOVERED DURING ANCHOR BOLT REMOVAL THAT THE ANCHOR BOLT WAS BROKEN. THE BREAK WAS AT THE POINT OF ATTACHMENT OF THREADS. THE SURGEON OPTED TO LEAVE IN THE SMALL PLASTIC THREADS IN PLACE RATHER THAN REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522805 BA-320-185 BONE ANCHOR HOA BIOTEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1