BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9260383 · Received October 31, 2019

    Report

    Report Number
    1030489-2019-01233
    Event Type
    Injury
    Date Received
    October 31, 2019
    Report Date
    October 31, 2019
    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 PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 1476006150, 510K # K121680, UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. 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. 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 DEBRIDEMENT PROCEDURE SURGERY AT C4 DUE TO INFECTION. POST-OP, PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION IN WHICH BROKEN ROD WAS REMOVED. REPORTEDLY THE INFECTION CAUSED ROD LOOSENING AND BREAKAGE THROUGH THE SKIN AND PROTRUDED OUTSIDE THE PATIENT¿S BODY. BONE BREAKAGE AND WORSENING OF KYPHOSIS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053712 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0243372W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R