BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 22139010 · Received June 4, 2025

    Report

    Report Number
    1030489-2025-02134
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Report Date
    June 4, 2025
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: COUNTRY OF ORIGIN IS JAPAN. G3: THE DEVICE P/N 1556300500 IS SIMILAR TO THE DEVICE MANUFACTURED IN US P/N 1556000500. HENCE, MENTIONED 510K LICENSE NUMBER K111942 IS OF P/N 1556000500. THIS EVENT IS BEING REPORTED ONLY AS A MALFUNCTION BECAUSE OF THE SIMILAR DEVICE REQUIREMENT IN 803 WHICH IS LIMITED TO MALFUNCTIONS. H6: 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. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING POSTERIOR FIXATION SPINAL THERAPY FOR OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT. IT WAS REPORTED THAT THE ROD IS FRACTURED. THERE WAS NO PATIENT SYMPTOM REPORTED. REPEAT SURGERY SCHEDULED FOR (B)(6). ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE BOTH SIDES ROD BREAKAGE NEAR THE TOP OF T10 FIXED RANGE  T3/4/5, SKIPS BETWEEN  T10/11/12, T6/7/8/9 OTSUKA METHOD. THE ROD WAS REMOVED AND REPLACED WITH TITANIUM ALLOY 5.5MM.  2 GCS WERE PLACED, 10 CM GRS WERE PLACED, AND THE OPERATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993691 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS 1556300500 0811439W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention