BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUTRAK BONE SCREW

    MDR report key: 18694 · Received September 30, 1994

    Report

    Report Number
    18694
    Event Type
    Injury
    Date Received
    September 30, 1994
    Date of Event
    August 1, 1994
    Report Date
    September 15, 1994
    Manufacturer
    ACUMED, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 25 MM SCREW WAS SELECTED AND INSERTED, BUT AT ABOUT THE POINT WHERE IT WAS 3 MM FROM INSERTION, THE SCREWDRIVER SNAPPED OFF AND A MEDIAL ARTHROTOMY WAS PERFORMED TO RETRIEVE. COULD NOT REMOVE, SO A HOLLOW-CORE DRILLING OVER THE SCREW WAS DONE. THIS WAS ONE OF THE LARGE FRAGMENT SCREWS THAT WAS 25 MM IN LENGTH. IT WAS REMOVED AND THE BONY FRAGMENT COULD BE FELT. SINCE THERE WAS A TUNNEL WHERE THE HOLLOW-CORE DRILLING HAD BEEN DONE, CANCELLOUS BONE WAS PACKED FOR THE OSTEOCHONDRAL PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUTRAK BONE SCREW 25.0 MM HEADLESS/CANNULATED BONE SCREW HWC ACUMED, INC. 2476-D

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention