BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION ROD

    MDR report key: 1033980 · Received April 24, 2008

    Report

    Report Number
    1649384-2008-00218
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 24, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. EVALUATION IS PENDING.

    Description of Event or Problem · 1

    IN 2008, THE SALES REPRESENTATIVE REPORTED THAT DURING SURGERY, THE SURGEON WAS POSITIONING THE HARMONY FLEXIBLE ARM WHEN THE KNOB/HANDLE THAT TIGHTENS THE ARM IN PLACE DID NOT HOLD ITS GRIP. WHEN ATTEMPTED TO TIGHTEN IT FURTHER, A BOLT/NUT FLEW OFF THE INSTRUMENT ONTO THE PATIENT. THE PIECES WERE RETRIEVED BY THE SURGEON. ADDITIONAL INFORMATION RECEIVED ON APRIL 21, 2008, VIA TELEPHONE, THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON WAS ABLE TO FINISH THE CASE BY POSITIONING THE ARM IN A WAY THAT IT WAS STIFF ENOUGH TO STAY TO USE IT AS INTENDED. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION ROD HARMONY LXH ABBOTT SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention