BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1770342 · Received July 21, 2010

    Report

    Report Number
    1030489-2010-00943
    Event Type
    Injury
    Date Received
    July 21, 2010
    Report Date
    June 21, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT. THE USER FACILITY SENT THE BROKEN SCREWS TO THE AUSTRALIAN REGULATOR AUTHORITY. THE TWO CONCOMITANT, UNBROKEN SCREWS WERE RETURNED TO THE MANUFACTURER. MACROSCOPIC EXAMINATION DID NOT REVEAL ANY MATERIAL OR FUNCTIONAL DEFECT REGARDING THE RETURNED IMPLANTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A FUSION SURGERY AT L5 - S1 USING POSTERIOR FIXATION AND AN INTERBODY DEVICE. THE PT HAD X-RAYS PERFORMED AT 3 MONTHS POST-OP SHOWING BREAKAGE OF BOTH S1 SCREWS AT BONE-SCREW INTERFACE AND FUSION HAD NOT OCCURRED. NINETY-EIGHT DAYS POST-OP, THE PT UNDERWENT A REVISION SURGERY TO REMOVE THE BROKEN SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM BONE SCREW KWQ MEDTRONIC SOFAMOR DANEK NA H09K6394

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention IMPLANT DATE:| EXPLANT DATE:| IMPLANT DATE:| EXPLANT DATE:| BONE SCREWS: PART# 75446545, LOT# H09K6394| CAPSTONE INTERBODY DEVICE