BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 24766582 · Received April 2, 2026

    Report

    Report Number
    2647346-2026-00175
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 2, 2026
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    KWP
    UDI-DI
    00643169384613
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE WITH CATALOG # 55811015540, UPN# (B)(4) AND 510K # K122433 WAS CLEARED IN THE UNITED STATES. 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SCREW USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WHEN THE SLEEVE OF THE LONG RETAINING DRIVER WAS SECURELY TIGHTENED AND ATTACHED, THE SCREW HEAD WAS NOT FIXED TO THE SCREW SHANK, RESULTING IN FREE-SPINNING OF THE SCREW HEAD. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823248 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT PUERTO RICO OPERATIONS CO, MED REL 55740017545 H6127871 00643169384613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown