BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO RING

    MDR report key: 1303103 · Received January 25, 2009

    Report

    Report Number
    1303103
    Event Type
    Malfunction
    Date Received
    January 25, 2009
    Date of Event
    December 24, 2008
    Report Date
    January 25, 2009
    Manufacturer
    OSSUR AMERICAS
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ONE SPECIFIC LOT OF HALO RINGS PROVED TO BE FAULTY IN THE MANNER THAT THE THREADS ON THE RING WERE TAPPED TOO TIGHTLY TO ACCEPT THE CERAMIC PIN WITHOUT TORQUE. THERE WERE A COUPLE OF PREVIOUS PATIENTS THAT WE NOTICED THIS PROBLEM ON BUT THE PROBLEM WAS SO SEVERE THAT THE PINS WOULD NOT THREAD AT ALL SO THE RINGS WERE NOT USED AND THE PINS NEVER EVEN GOT CLOSE TO THE PATIENT'S HEAD. NO PENETRATION. WHEN THIS HAPPENED THE RING WAS REPLACED AND ENSURED THAT THE PINS THREADED SMOOTHLY. THE MANUFACTURER HAS NOTIFIED OUR FACILITY THAT THEY HAVE IMPLEMENTED SEVERAL CHANGES AND CORRECTIVE ACTIONS TO THEIR MANUFACTURING PROCESS TO CORRECT THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO RING HOLDER, HEAD, NEUROSURGICAL HBL OSSUR AMERICAS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR