BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6610613 · Received June 5, 2017

    Report

    Report Number
    1030489-2017-01447
    Event Type
    Injury
    Date Received
    June 5, 2017
    Report Date
    May 10, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    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 PRODUCT IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 7040750 510K# K040962 AND UPN (B)(4) IS APPROVED FOR THE MARKET USE IN THE US. (B)(4). 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

    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

    PRE-OP DIAGNOSIS: LOW BACK PAIN. LEVELS INVOLVED: TH11/ILIAC. PROCEDURE: SCREW REPLACEMENT AND PEDICLE SUBTRACTION OSTEOTOMY AT L4 IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT A SCOLIOSIS CORRECTION PROCEDURE. POST-OP, PATIENT COMPLAINED OF BACK PAIN. THE IMPLANTED ILIAC SCREWS WERE FOUND TO BE LOOSENED. A REVISION SURGERY WAS PERFORMED FOR SCREW REMOVAL AND REPLACEMENT. PATIENT ALSO UNDERWENT EXTENSION OF FIXATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392945 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0108994W

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R