BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6766365 · Received August 4, 2017

    Report

    Report Number
    1030489-2017-01864
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    July 10, 2017
    Report Date
    July 11, 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# 1476006150, 510K# K121680 AND (B)(4) HAS BEEN CLEARED FOR US. (REVISION SURGERY) 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

    PROCEDURE USED: POSTERIOR SPINAL FUSION LEVELS IMPLANTED: L2-S2AI IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE ROD BROKE INSIDE THE PATIENT. PATIENT UNDERWENT A REVISION SURGERY FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548383 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention