BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 8247261 · Received January 15, 2019

    Report

    Report Number
    1030489-2019-00060
    Event Type
    Injury
    Date Received
    January 15, 2019
    Report Date
    January 15, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 55811016545, 510K# K122433, AND (B)(4) IS APPROVED FOR MARKET IN THE US. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. 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 WAS PRE-OPERATIVELY DIAGNOSED WITH COMPRESSION FRACTURE OCCURRED AT T12 AND UNDERWENT PPS 1 ABOVE-1 BELOW FIXATION (PERCUTANEOUS PEDICLE SCREW FIXATION) SURGERY AT TH11/L1 LEVELS. POST-OPERATIVELY, THE SCREW ON THE RIGHT OF L1 BROKE UNDER THE SCREW HEAD. THE FRAGMENT IS STILL REMAINING IN THE PATIENT. THE PATIENT CAME TO THE OUTPATIENT SINCE THE PATIENT HAD A PAIN IN LOWER BACK, AND THE BREAKAGE OF THE SCREW WAS NOTICED BY CT. THERE WERE NO COMPLICATIONS OF BACKACHE THAT ASSOCIATED WITH SCREW BREAKAGE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43723 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA CA16D031

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other