BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEVO CERVICAL PLATE SYSTEM

    MDR report key: 23231352 · Received October 7, 2025

    Report

    Report Number
    3003120897-2025-00321
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 9, 2025
    Report Date
    February 16, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    HXX
    UDI-DI
    00643169342293
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART # 3030007, LOT # K24C1129 VISUAL AND OPTICAL EXAMINATION REVEALED THE PORTION OF THE DRIVER¿S TIP THAT INTERFACES WITH THE SCREW IS BROKEN. THE DAMAGE TO THE DRIVER IS CONSISTENT WITH 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.

    Additional Manufacturer Narrative · 0

    RADIOGRAPHIC ASSESSMENT CONCLUDED THAT LATERAL X-RAY SHOWS THREE LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) UNCOUNTABLE, NO OBVIOUS HARDWARE COMPLICATION. 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.

    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

    ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE OTHER SCREWS WERE IMPLANTED PROPERLY IN TO THE PLATE WITHOUT ANY FRAGMENTS. THERE IS NO REVISION SURGERY PLANNED FOR EXTRACTION OF THE SCREWS OR THE PLATE. THE SCREW DRIVER TIP WAS HARD TO RETRIEVE SO ITS IN THE SCREW HEAD.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR C4-C7 REVISION AND FIXATION. IT WAS REPORTED THAT THE TIP WAS BROKEN ON TWO DIFFERENT DRIVERS WHEN THE SCREW WAS USED IN THE NORMAL HOLE AND NOT THE SLOT HOLE. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT PROCEDURE INVOLVED IN THE EVENT WAS ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) WITH CAGES AND PLATE. THERE WERE BROKEN FRAGMENTS OF DRIVER KEPT IN THE SCREW HEAD AS IT COULDN¿T BE REMOVED. THIS WAS ALSO DUE TO USER ERROR AS A 4.5MM SLOT SCREW SHOULD ONLY BE USED IN A SLOT HOLE AND NOT IN A NORMAL HOLE MADE FOR 3.5/4.0MM VA SD/ST SCREWS. THE PROCEDURE WAS LONGER BUT THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116152 ZEVO CERVICAL PLATE SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC. 3030007 K24C1129 00643169342293

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female