BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 24480942 · Received March 2, 2026

    Report

    Report Number
    2647346-2026-00095
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    January 19, 2026
    Report Date
    March 2, 2026
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    NKB
    PMA / PMN Number
    K091974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE KYPHOSIS WITH T12 COMPRESSION FRACTURE. PLAIN FILMS ARE PERFORMED AND REVIEWED TO EVALUATE PAIN DEMONSTRATE A KYPHOTIC SEGMENT ABOVE WITH SCREWS POTENTIALLY FRACTURE FROM THE TIP OF THE SCREWS OUT BUT NOT INTO THE ENDPLATE. SCHEDULED FOR REVISION T10-S1 FUSION. SITE RELATED ASSESSMENT: PROBABLE TO STUDY DEVICE AND THE PROCEDURE INDEX SURGERY. SPONSOR RELATED ASSESSMENT: NOT RELATED TO PROCEDURE, PROBABLE RELATED TO DEVICE OUTCOME STATUS NOT RECOVERED/NOT RESOLVED ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT THERE IS NO ALLEGATION AGAINST DBM GRAFTON PUTTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538489 CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT PUERTO RICO OPERATIONS CO, MED REL 54840006550 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male