BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CFE CANNULATED SCREW, 24MM

    MDR report key: 30320 · Received February 16, 1996

    Report

    Report Number
    MW1008377
    Event Type
    Injury
    Date Received
    February 16, 1996
    Date of Event
    January 24, 1996
    Report Date
    February 16, 1996
    Manufacturer
    ACE MEDICAL CO.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF 6.5MM CANNULATED "TITANIUM" SCREW, THE SCREW COMPLETELY SHATTERED AT THE NECK-THREADED JUNCTION. THE SCREW AND PROXIMAL SHAFT WERE SUBSEQUENTLY REMOVED. ATTEMPTS WERE MADE TO REMOVE THE THREAD PART OF THE BROKEN SCREW WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CFE CANNULATED SCREW, 24MM BONE SCREW HWC ACE MEDICAL CO. 14188-70 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention