BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACF DISTRACTION SCREW 12MM ONE

    MDR report key: 1220335 · Received November 3, 2008

    Report

    Report Number
    2430952-2008-00033
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    INSTRUMEND INTERNATIONAL
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE RECEIVED DISTRACTION SCREWS AND THE OUTER PACKAGING HAD BEEN LABELED SIZE 12MM BUT WHAT WAS INSIDE THE BOX WAS 16MM. TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACF DISTRACTION SCREW 12MM ONE VERTEBRAL BODY DISTRACTION SYSTEM MQP INSTRUMEND INTERNATIONAL 326081

    Patients

    Seq Age Sex Outcome Treatment
    1