BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6914452 · Received October 4, 2017

    Report

    Report Number
    1030489-2017-02146
    Event Type
    Malfunction
    Date Received
    October 4, 2017
    Date of Event
    September 6, 2017
    Report Date
    September 6, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 55811015550, 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.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE SCOLIOSIS IT WAS REPORTED THAT PATIENT UNDERWENT SCOLIOSIS CORRECTION FUSION. INTRA-OP, THE INSERTED SCREW PENETRATED INWARD. IT WAS RE-INSERTED DURING THE SURGERY. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693667 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA CA16E024

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR