BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1914580 · Received December 3, 2010

    Report

    Report Number
    1030489-2010-01541
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 11, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INC
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF IMAGES PROVIDED FOUND MULTIPLE FILMS/PHOTOS OF MAJOR RECONSTRUCT. PYRAMESH CAGE PLACED AT THORACOLUMBAR SPINE AFTER SUPERIOR PARTIAL CORPECTOMY. PEDICLE SCREW FIXATION NOTED 4 LEVELS ABOVE, 3 LEVELS BELOW. PHOTOS SHOW CICUMFERENTIAL DECOMPRESSION. NO EVIDENCE OF ROD BREAKAGE IS NOTED ON THESE PICTURES AS REPORTED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION SURGERY TO TREAT ADULT DEFORMITY. APPROXIMATELY THREE YEARS POST-OP, IT WAS NOTED THAT A ROD HAD BROKEN, AND A PSEUDOARTHROSIS HAD DEVELOPED AT ONE OF THE LEVELS OF THE FUSION CONSTRUCT. THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE ROD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention