BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UCR SPINAL SYSTEM

    MDR report key: 5376768 · Received February 5, 2004

    Report

    Report Number
    2032593-2004-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2004
    Date of Event
    January 9, 2004
    Report Date
    January 28, 2004
    Manufacturer
    SEASPINE, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DATE RECEIVED BY MANUFACTURER: 09/19/2003, 10/16/2003. ADDITIONAL DEVICE MANUFACTURE DATE: 09/01/2003, 10/01/2003. NO VISUAL SIGNS OF PRODUCT FAILURE. IT APPEARS THAT THE PRODUCT BECAME UNSCREWED IN VIVO.

    Description of Event or Problem · 1

    PT REQUIRED RE-OPERATION FOR A T12-L2 SPINAL FUSION PERFORMED ON (B)(6) 2004. PRE-OP X-RAY SHOWED DISENGAGEMENT OF CAUDAL LOCKING SET SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UCR SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM KWP SEASPINE, INC. NA A204C, A0362A, A0360A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention