BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILITY PIN RET BLADE

    MDR report key: 22952990 · Received September 3, 2025

    Report

    Report Number
    3003120897-2025-00171
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    June 30, 2025
    Report Date
    September 3, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. 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 (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING ANTERIOR DISCOPLASTY THERAPY FROM L5 TO S1. IT WAS REPORTED THAT THE STABILITY PIN FRACTURED INTRAOPERATIVELY, RESULTING IN THE TIP OF THE TOOL REMAINING INSIDE THE VERTEBRAL BODY AND BEING UNABLE TO BE REMOVED. THE BREAKAGE OCCURRED BETWEEN THE SMOOTH PART AND THE THREAD OF THE INSTRUMENT. THE EVENT WAS ASSOCIATED WITH PERMANENT INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733917 STABILITY PIN RET BLADE RETRACTOR GAD MEDTRONIC SOFAMOR DANEK USA, INC. 897-406 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown