BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEVO CERVICAL PLATE SYSTEM

    MDR report key: 21392520 · Received February 18, 2025

    Report

    Report Number
    1030489-2025-00821
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 22, 2025
    Report Date
    April 10, 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
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3030007, SERIAL/LOT #: (B)(6), UDI#: (B)(4); PRODUCT ID: 3030007, SERIAL/LOT #: (B)(6) AND UDI#: (B)(4). 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

    H3: PRODUCT ANALYSIS : PART # 3030007 : LOT # K24A1505 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. THE DRIVER MAY HAVE NOT BEEN SEATED ALL THE WAY DOWN IN THE HEAD OF THE SCREW BEFORE USE. THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL OVERLOAD. PRODUCT ANALYSIS : PART # 3030007 : LOT # K24A1505 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. THE DRIVER MAY HAVE NOT BEEN SEATED ALL THE WAY DOWN IN THE HEAD OF THE SCREW BEFORE USE. THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL OVERLOAD. PRODUCT ANALYSIS : PART # 3030007 : LOT # IM18H021 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. THE DRIVER MAY HAVE NOT BEEN SEATED ALL THE WAY DOWN IN THE HEAD OF THE SCREW BEFORE USE. THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE INSTRUMENTS. IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205532 ZEVO CERVICAL PLATE SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC 3030007 K24A1505 00643169342293

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11....".| SEE H11.