BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    MDR report key: 21320676 · Received February 6, 2025

    Report

    Report Number
    1030489-2025-00599
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    December 12, 2023
    Report Date
    February 6, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    UDI-DI
    00643169754539
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS #706071912 : PART # 6550006, LOT# K22L1160 VISUAL AND OPTICAL EXAMINATION ANALYSIS REVEALS THAT THE LOCKING TABS HAVE BEEN BENT INWARDS OF THE TIP OF THE DRIVER WHICH WILL NOT ALLOW THE CENTER SHAFT OF THE INSTRUMENT TO FUNCTION AND THE RETAINING PIN HAS BEEN BENT AND THE HEX EDGES OF THE COMPRESSOR HAVE BEEN ROUNDED. THIS IS CONSISTENT WITH BEND STRESS OVERLOAD. 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 A MANUFACTURER REPRESENTATIVE REGARDING DRIVERS, ROD INSERTER, REDUCER, PEDICLE MARKER, AND A PROBE HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. 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
    919837 CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC 6550006 K22L1160 00643169754539

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown