BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 6812686 · Received August 23, 2017

    Report

    Report Number
    1030489-2017-01951
    Event Type
    Injury
    Date Received
    August 23, 2017
    Date of Event
    July 27, 2017
    Report Date
    July 27, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    REFER H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 55811014535, 510K# K122433 AND UDI (B)(4) IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT UNDERWENT SURGERY DUE TO COMPRESSION FRACTURE USING CANNULATED SAGITTAL ADJUSTING SCREW. IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE SCREW BROKE. REPORTEDLY, AS THE HEAD PART OF THE LEFT L3 SCREW CAME OFF, THE LEFT L3 SCREW WAS EXPLANTED BY SHAVING THE PEDICLE AND REMOVING THE SCREW WITH PLIERS. IT WAS HARD TO CONFIRM BEFORE THE REMOVAL BUT IT HAS BEEN BROKEN. AS A RESULT, A REVISION SURGERY WAS PERFORMED TO REPLACE THE BROKEN SCREW ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592608 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention