BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEVO CERVICAL PLATE SYSTEM

    MDR report key: 21330772 · Received February 7, 2025

    Report

    Report Number
    1030489-2025-00624
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 6, 2025
    Report Date
    June 25, 2025
    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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS FOR PART # 3030007; LOT # IM20F008 VISUAL AND OPTICAL EXAMINATION REVEALED THE PORTION OF THE DRIVER¿S TIP THAT INTERFACES WITH THE SCREW HAS BEEN WORN/STRIPPED CONSISTENT WITH INTERFACE DURING USAGE. THE TORX EDGES HAVE BEEN SLIGHTLY ROLLED OVER AND DEFORMED. THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL OVERLOAD AND REPEATED USE. 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

    G2: COUNTRY OF ORIGIN IS JAPAN. 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 CERVICAL ANTERIOR FUSION SPINAL THERAPY. IT WAS REPORTED THAT THERE IS DAMAGE TO THE SCREWDRIVER TIP. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE TIP OF THE DRIVER IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247530 ZEVO CERVICAL PLATE SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC 3030007 IM20F008 00643169342293

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown