BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1082263 · Received July 24, 2008

    Report

    Report Number
    1030489-2008-00366
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 26, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NQP
    PMA / PMN Number
    K050809
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE RETURNED TO A THIRD PARTY FACILITY FOR EVALUATION. EVALUATION IS CURRENTLY IN PROGRESS. ALTHOUGH THE SUSPECT DEVICES ARE UNK THE FOLLOWING SCREWS WERE RETURNED: Y7225535 LOT W05J6445, Y7225540 LOT W06A0576, AND Y7225540 LOT W05J6446. A REVIEW OF THE DEVICE HISTORY RECORDS FOR EACH RETURNED LOT FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. TWO X-RAYS TAKEN AT AN UNK TIME POST-OP WERE RETURNED FOR EVALUATION. EXAMINATION CONFIRMED POSTERIOR CONSTRUCT AT L4-S1 WITH INTERBODY DEVICE AT L5 AND APPARENT SOLID FUSION. NO LYSIS OR LOSS OF FIXATION IS APPARENT AROUND THE SCREWS. NO INTERBODY DEVICE NOTED AT L4-5.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT SURGERY FOR L4-S1 FUSION WITH SEMI RIGID POSTERIOR ROD FIXATION. IT WAS REPORTED THAT THE PT UNDERWENT A REVISION SURGERY APPROXIMATELY 2 YEARS POST-OP IN 2008, DUE TO PEDICLE SCREW LOOSENING. IT WAS REPORTED THAT THERE WAS FUSION AT L5-S1, NON FUSION AT L4-5. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SCREW NQP WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention