BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY

    MDR report key: 21186421 · Received January 18, 2025

    Report

    Report Number
    1030489-2025-00228
    Event Type
    Malfunction
    Date Received
    January 18, 2025
    Date of Event
    February 24, 2023
    Report Date
    January 18, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    UDI-DI
    00763000193980
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART: 4680009, LOT# K22H1110 AFTER VISUAL AND OPTICAL EXAMINATION, IT APPEARS THAT THE TIP OF THE DRIVER SHAFT HAS BEEN BROKEN OFF FROM WHAT APPEARS TO BE OVERLOAD. THIS IS CONSISTENT WITH OVERLOAD AT SOME TIME. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE REPRESENTATIVE) REGARDING MULTIPLE INSTRUMENTS. IT WAS REPORTED THAT WHEN THE DOCTOR WAS HAMMERING IN THE AWL, THE AWL GOT BENT AND STUCK INSIDE THE AWL SLEEVE AND THE DRIVER BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058421 ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC 4680009 K22H1110 00763000193980

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown