BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACF DISTRACTION SCREW 12MM ONE

    MDR report key: 1202753 · Received October 9, 2008

    Report

    Report Number
    2430952-2008-00027
    Event Type
    Other
    Date Received
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    INSTRUMED INTERNATIONAL
    Product Code
    LXH
    Removal / Correction Number
    `
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. THE ACTUAL DEVICE WAS DISCARDED BY THE CUSTOMER. ALL OTHER UNUSED, MISLABELED PRODUCTS ARE BEING RETURNED FOR EVAL. INTEGRA LIFESCIENCES CORPORATION IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR J. JAMNER SURGICAL INSTRUMENTS.

    Description of Event or Problem · 1

    THE USER FACILITY ORIGINALLY REPORTS THAT THEY ARE SENDING BACK 5 EACH #R-6367A, LOT #32608, BECAUSE 16MM SCREWS WERE PACKAGED IN BAGS LABELED 12MM. THE CUSTOMER BELIEVES THEY MAY HAVE DISCARDED THE 6TH SCREW. THE USER FACILITY REPORTS TODAY THAT THE INCIDENT WAS DISCOVERED DURING AN ANTERIOR CERVICAL DISC FIXATION PROCEDURE, AND THAT THERE WAS PT CONTACT WITH THE DEVICE, BUT THERE WAS NO PT INJURY. THE SCREW THAT WAS USED WAS SAID TO BE DISCARDED, THEREFORE NOT RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1