BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7640494 · Received June 27, 2018

    Report

    Report Number
    1030489-2018-00908
    Event Type
    Injury
    Date Received
    June 27, 2018
    Report Date
    June 27, 2018
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 55811015545 AND 510K# K122433 AND UDI# (B)(4) IS APPROVED FOR SALE IN THE US. PRODUCT WAS NOT 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 UNDERWENT VERTEBROPLASTY WITH 'HA' AT L1 DUE TO L2 COMPRESSION FRACTURE. PERCUTANEOUS CORRECTION FUSION WAS PERFORMED FROM POSTERIOR SIDE ON 1A1B. POST-OP, THE HEAD BASE (THE TRANSITION PART WITH THE SCREW SHAFT) OF THE L1 SCREW BROKE. THE PATIENT UNDERWENT REMOVAL OF THE SCREW. HOWEVER, TIP OF THE SCREW REMAINED INSIDE THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486037 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA CA13H028

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention