BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM

    MDR report key: 22173744 · Received June 10, 2025

    Report

    Report Number
    1030489-2025-02181
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    March 27, 2025
    Report Date
    June 10, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    OLO
    UDI-DI
    00643169524842
    PMA / PMN Number
    K150135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART# 2160212, LOT# RS15G018 VISUAL INSPECTION CONFIRMED THE TABS ON THE GUIDE HAVE BEEN BENT DUE TO OVERLOAD. 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 USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT AFTER SURGERY, THE THREADS BROKE OFF THE RASP WHEN ATTEMPTING TO REMOVE IT AND THE INNER TUBE OF THE ALIF SCREW GUIDE APPEARED TO BE BENT INSIDE THE INSTRUMENT. THE HANDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654734 DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC SOFAMOR DANEK USA, INC 2160212 RS15G018 00643169524842

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown