BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYAXIAL PEDICLE SCREW 6.5 X 45

    MDR report key: 1253074 · Received December 5, 2008

    Report

    Report Number
    1649384-2008-00578
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    September 3, 2008
    Report Date
    December 5, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    MCV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN LATE 2008, THE DISTRIBUTOR REPORTED THAT DURING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AFTER THE SURGEON HAD IMPLANTED A SCREW, THE SURGEON WAS ADJUSTING THE SCREW POSITION WITH THE DRIVER WHEN THE SCREW HEAD DISASSEMBLED AS THE DRIVER WAS PULLED OUT. ON NINE DAYS LATER, THE DISTRIBUTOR REPORTED THAT THE SURGEON WAS ABLE TO EXPLANT THE DISASSEMBLED SCREW WITH THE PATHFINDER BONE SCREW ADJUSTER. THE SURGEON THEN IMPLANTED A NEW SCREW. THERE WAS A 20 MINUTE SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYAXIAL PEDICLE SCREW 6.5 X 45 PATHFINDER MCV ABBOTT SPINE 48WF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention