BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6607345 · Received June 2, 2017

    Report

    Report Number
    1030489-2017-01416
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    May 10, 2017
    Report Date
    May 10, 2017
    Manufacturer
    SOFAMOR DANEK
    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: KYPHOSIS DUE TO COMPRESSION FRACTURE PROCEDURE USED: POSTERIOR FUSION AT T11-L2 / KYPHOSIS CORRECTION PROCEDURE WITH TRAUMA LEVELS: T11-L2 IT WAS REPORTED THAT X-RAYS AND CTS TAKEN AFTER INSERTION OF THE SCREW DURING SURGERY, REVEALED THAT THE L2 RIGHT SCREW WAS FOUND TO BE INSERTED IN THE VERTEBRAL BODY NOT VIA THE PEDICLE FROM LATERAL SIDE. THE OBSERVATION WAS MADE AFTER INSERTING THE ROD AND CLOSING THE INCISION. THE SCREW WAS REINSERTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388510 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1