BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX(TM) SYSTEM

    MDR report key: 21660846 · Received March 21, 2025

    Report

    Report Number
    1030489-2025-01484
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    August 2, 2023
    Report Date
    March 21, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HRX
    UDI-DI
    00673978085456
    PMA / PMN Number
    K993021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER DETAILS ARE UNKNOWN G2: COUNTRY OF ORIGIN - JAPAN H3: PRODUCT ANALYSIS PRODUCT: (B)(4), LOTNO:1781176 DURING THE INSPECTION AT THE TIME OF ACCEPTANCE, THE REQUESTED PHENOMENON WAS CONFIRMED IT WAS CONFIRMED THAT THE OUTER TUBE WAS BRO KEN. 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 A HEALTHCARE PROVIDER REGARDING A DEVICE USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE IMAGE WAS NOT CLEAR. THERE WAS NO KNOWN PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRE-OP DIAGNOSIS WAS DISC HERNIATION, THE PROCEDURE INVOLVED WAS MED. THE DEVICE WAS NOT USED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT OCCURRED ON THE BACK TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309151 METRX(TM) SYSTEM ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC 9560101 1781176 00673978085456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown