BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2200097 · Received August 10, 2011

    Report

    Report Number
    1030489-2011-01020
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K040583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROD HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.MACROSCOPIC EXAMINATION CONFIRMS ROD BROKEN. SIGNIFICANT DAMAGE NOTED ON FRACTURE SURFACES. MICROSCOPIC EXAMINATION OF FRACTURE SURFACE REVEALS A FAIRLY FLAT FRACTURE, WITH PROGRESSIVE STRIATIONS, INDICATIVE OF FATIGUE, FOLLOWED BY ULTIMATE FAILURE OF THE IMPLANT, CONSISTENT WITH FAILURE DUE TO CYCLIC BENDING FATIGUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SURGICAL PROCEDURE. SOMETIME POST OP THE PATIENT HEARD AND FELT A POP IN THE PATIENT. X-RAYS REVEALED A FRACTURED ROD JUST ABOVE RIGHT S1 PEDICLE SCREW. THE PATIENT UNDERWENT REVISION SURGERY AND ALL HARDWARE WAS REMOVED BECAUSE SOLID FUSION HAD OCCURRED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SCREWS