BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD HOLDER

    MDR report key: 1080966 · Received July 23, 2008

    Report

    Report Number
    1649384-2008-00396
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. EVAL IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    ON JULY 21 2008 THE OFFICE MANAGER SENT AN EMAIL REPORTING THAT DURING SURGERY THE HANDLE BROKE. ADDITIONAL INFO RECEIVED ON 07/22/2008 VIA TELEPHONE, THE SALES REPRESENTATIVE REPORTED THAT DURING SURGERY AT THE END OF THE CASE WHEN THE SURGEON WAS IMPLANTING THE ROD THE RATCHETING HANDLE CAME APART INTO THREE PIECES ONTO THE FIELD. THE SCREW SEEMED TO HAVE BACKED OUT. ALL THE PIECES WERE RETRIEVED AND THE SURGEON WAS ABLE TO FINISH THE CASE WITH ANOTHER ROD HOLDER. AFTER THE CASE THE SCRUB TECH WAS ABLE TO PLACE THE INSTRUMENT BACK TOGETHER AND PLACE THE SCREW THAT HAD BACKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROD HOLDER PATHFINDER HXX ABBOTT SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention