BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTESTACK CORNERSTONE PSR

    MDR report key: 24804429 · Received April 7, 2026

    Report

    Report Number
    3003120897-2026-00662
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 7, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MQP
    UDI-DI
    00885074354323
    PMA / PMN Number
    K111264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    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 USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE INSTRUMENTS. IT WAS REPORTED THAT DURING FIELD CONTACT, THE FOLLOWING DEVICE-RELATED ISSUES AND MALFUNCTIONS WERE IDENTIFIED: THE SLEEVE 7967028 INSERTER WOULD NOT ATTACH WITH TRIAL, THE SHAFT 2161001 OLIF25 INTERBODY THREADED HAD A TIP THAT BROKE OFF, THE INSERTER 4360113 13MM INSERTER CASE WAS NOT ATTACHING, AND THE DRIVER 6630904 T8/T10 DRIVER WAS STRIPPED. TIP BROKE OFF FOR INSERTER 6279002 PSR ENDCAP THREADED. DRIVER 7080907 2.5 HEX SCREWDRIVER (QTY-2) WERE STRIPPED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560867 VERTESTACK CORNERSTONE PSR SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC. 6279002 SW20M076 00885074354323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown