BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACF DISTRACTION SCREWS 14MM, S

    MDR report key: 974743 · Received December 28, 2007

    Report

    Report Number
    2430952-2007-00056
    Event Type
    Malfunction
    Date Received
    December 28, 2007
    Report Date
    December 28, 2007
    Manufacturer
    INSTRUMED INTL INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DISTRACTION SCREWS BROKE OFF A THE TIP IN THE PATIENT WHILE IT WAS BEING RETRACTED. THE REMOVAL REQUIRED DRILLING OUT THE TIPS REMAINING IN THE CERVICAL BONE. THE SUPPLIER HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACF DISTRACTION SCREWS 14MM, S SURGICAL INSTRUMENTS HWC INSTRUMED INTL INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *