BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 21065319 · Received January 3, 2025

    Report

    Report Number
    1030489-2025-00046
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    May 9, 2023
    Report Date
    January 3, 2025
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    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

    G2: COUNTRY OF ORIGIN - JAPAN G4 - THIS PRODUCT IS NOT MARKETED IN US BUT A SIMILAR DEVICE WITH PRODUCT NUMBER (B)6) WITH 510(K)# K121680 AND UDI (B)(4) IS MARKETED IN US. H3: PRODUCT ANALYSIS # (B)(6): # 0858031W AFTER VISUAL AND OPTICAL EXAMINATION AND FUNCTIONAL TESTING, IT DOES NOT APPEAR TO BE ANY DAMAGE NOR DOES IT INDICATE ANY FUNCTIONAL ISSUES WITH THE ROD. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 PATIENT HAVING POSTERIOR THORA CIC FUSION FOR THORACIC VERTEBRA RUPTURE FRACTURE. IT WAS REPORTED THAT WHILE OPENING THEROD AND BENDING IT, A CRACKLING METALLIC SOUND OCCURRED. SINCE THERE WAS A POSSIBILITY OF BREAKAGE, THE ROD WAS REPLACED WITH A NEW ONE AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THIS ROD WAS NEVER IMPLANTED. PRODUCT WILL BE RETURNED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457855 CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WARSAW ORTHOPEDICS 1555106170 0858031W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown