BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP

    MDR report key: 24434729 · Received February 24, 2026

    Report

    Report Number
    1723170-2026-00307
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    December 15, 2025
    Report Date
    February 24, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    UDI-DI
    00885074244174
    PMA / PMN Number
    K990214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. G2: FOREIGN COUNTRY - JAPAN H3, H6: THE 9731780 CLAMP, LOT 180419 WAS RETURNED FOR EVALUATION. ANALYSIS FOUND PHYSICAL DAMAGE. THE RETURNED CLAMP WAS MISSING THE CYLINDER RECEPTACLE, RENDERING IT UNUSABLE. CODES B01, C07, AND D02 ARE APPLICABLE. 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

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS AN OPEN SPINE CLAMP FIXATION FAILURE. EVEN THOUGH THE SCREW WAS TURNED, THE CLAMP DID NOT TIGHTEN. THE PROCEDURE WAS COMPLETED USING THE NAVIGATION/IMAGE SYSTEM. THIS ISSUE CAUSED LESS THAN 1HOUR SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493916 OPEN SPINE CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 9731780 180419 00885074244174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown