BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI PEDICLE

    MDR report key: 2123095 · Received September 5, 2008

    Report

    Report Number
    3004774118-2008-00001
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    June 12, 2008
    Report Date
    July 12, 2008
    Manufacturer
    K2M, INC
    Product Code
    KWP
    PMA / PMN Number
    K042635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFECTS IN THE SET SCREW WERE IDENTIFIED IN THE RETRIEVAL ANALYSIS. THE WEAR PATTERN ON THE UNDERSURFACE OF THE SCREW WAS CONSISTENT WITH THE WEAR SEEN WHEN THE ROD HAS NOT BEEN FULLY SEATED DURING SURGERY AND CONSEQUENTLY LOOSENS. THIS IS A KNOWN COMPLICATION OF THIS PROCEDURE AND IS CAUTIONED IN THE PRODUCT INSERT. THE SURGICAL TECHNIQUE MANUAL CLEARLY DESCRIBES THE USE OF THE INSTRUMENTS TO FACILITATE FULL SEATING OF THE ROD. THE SCREW DIS-ASSEMBLY DURING REMOVAL WAS DUE TO THE EXCESSIVE APPLICATION OF FORCE.

    Description of Event or Problem · 1

    THE L5 SET SCREW LOOSENED FROM THE PEDICLE SCREW 3 MONTHS POST-OPERATIVELY AND REVISION SURGERY WAS PERFORMED TO REVISE THE SCREW. DURING THE PROCESS OF REMOVING THE PEDICLE SCREW, IT WAS DAMAGED AND HAD TO BE REMOVED IN PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENALI PEDICLE PEDICLE SCREW KWP K2M, INC 019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention