BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1060757 · Received June 12, 2008

    Report

    Report Number
    1030489-2008-00271
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 16, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVAL. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BONE SCREW WAS BROKEN POST-OP AT THE S1 LEVEL. NO REVISION SURGERY HAS TAKEN PLACE. NO PT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK