BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1122827 · Received August 14, 2008

    Report

    Report Number
    1030489-2008-00434
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Report Date
    July 17, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K032265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CANNULATED PEDICLE SCREW BREAKAGE 6 WEEKS POST-OP AT L5-S1. NO REVISION SURGERY HAS BEEN REPORTED. NO PATIENT COMPLICATIONS 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