BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6013455 · Received October 10, 2016

    Report

    Report Number
    1030489-2016-02825
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 12, 2016
    Report Date
    November 29, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K032265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    PRODUCT ANALYSIS: MACROSCOPIC AND OPTICAL EXAMINATION REVEALED LOCALIZED THREAD CREST/FLANK DAMAGE; FUNCTIONAL EVALUATION WITH A SAMPLE MAS HEAD FOUND THE SET SCREW WAS UNABLE TO BE FULLY ENGAGED. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH SET SCREW THREAD DAMAGE DURING CONSTRUCT ASSEMBLY.

    Additional Manufacturer Narrative · 1

    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 AN UNSPECIFIED PROCEDURE DUE TO BACK PAIN. DURING SURGERY, THE SURGEON FOUND ONE OF THE SCREW THREAD TO BE SLID. THE SURGEON USED ANOTHER SCREW TO COMPLETE THE SURGERY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665618 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0451768W

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR