BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILITY PIN RET BLADE

    MDR report key: 22994203 · Received September 8, 2025

    Report

    Report Number
    3003120897-2025-00192
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    July 3, 2025
    Report Date
    September 8, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PRODUCT:897-405, LOT:PZ21H002 VISUAL AND OPTICAL INSPECTION CONFIRMED THAT THE TIP OF THE STABILITY PIN HAS BEEN BENT DUE OVERLOAD. E1: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. 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 ANTERIOR LUMBAR INTERBODY FUSION THERAPY AT L5S1. IT WAS REPORTED THAT DURING THE PROCEDURE, DISCOVERED THAT A PIN OF THE ENDORING ANCILLARY DEVICE WAS STUCK IN THE VALVE. PRESENCE OF METAL PARTICLES NOTICED IN THE SURGICAL SITE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PIN HAS BEEN BROKEN AND STUCK IN THE ENDORING VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2066511 STABILITY PIN RET BLADE RETRACTOR GAD MEDTRONIC SOFAMOR DANEK USA, INC. 897-405 PZ21H002

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown