BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANT CER

    MDR report key: 865558 · Received June 15, 2007

    Report

    Report Number
    1649384-2007-00104
    Event Type
    Injury
    Date Received
    June 15, 2007
    Date of Event
    May 14, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    JDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    IN 2007, A SURGEON WAS IMPLANTING A 1 LEVEL ANTCER PLATE AND DURING INSERTION OF THE SECOND SCREW IN THE BOTTOM OF THE PLATE THE SWIVEL (SECURE RING) POPPED OUT. THE SURGEON REMOVED THE ORIGINAL PLATE AND USED ANOTHER PLATE TO COMPLETE SURGERY. SURGERY TIME EXTENDED FOR 2 MINS. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANT CER ANT-CER 1 LEVEL PLATE ASSEMBLY - 26 MM JDN ABBOTT SPINE, INC. NA 36JB

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention