BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1161233 · Received September 10, 2008

    Report

    Report Number
    1030489-2008-00500
    Event Type
    Injury
    Date Received
    September 10, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 11, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K052187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SETSCREW AND MULTI-AXIAL SCREW WERE RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION OF THE PEDICLE SCREW REVEAL WITNESS MARKINGS ON ONE SIDE OF THE ROD SOLT SUGGESTING THE ROD MAY NOT HAVE BEEN SEATED COMPLETELY. EXAMINATION OF THE SETSCREW REVEAL NO DAMAGE AND MARKINGS SUGGEST GOOD CONTACT WITH THE ROD. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIAGNOSED WITH SCOLIOSIS UNDERWENT SURGERY FOR IMPLANT OF POSTERIOR FIXATION WITH RODS AND PEDICLE SCREWS FROM T4-L3. X-RAYS TAKEN IN 2008 REVEAL A SETSCREW BACKED OUT OF THE LEFT L3 SCREW. THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SETSCREW KWP WARSAW ORTHOPEDIC INC. NA W06K1407

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention