BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINOUS PROCESS CLAMP

    MDR report key: 24364413 · Received February 17, 2026

    Report

    Report Number
    1723170-2026-00251
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    December 29, 2025
    Report Date
    March 27, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    UDI-DI
    00763000206598
    PMA / PMN Number
    K131425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE SPINOUS PROCESS SHORT CLAMP, LOT NUMBER: 230125, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE CLAMP WAS FOUND TO HAVE THE RETAINER CLIP MISSING. H6: CODES B01, C07, AND D02 ARE APPLICABLE TO THIS ANALYSIS. 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.

    Additional Manufacturer Narrative · 0

    H2: A CORRECTION HAS BEEN MADE FOR THE PREVIOUS INFORMATION IN SECTION B5. THE ISSUE OCCURRED DURING A PROCEDURE WITH A PATIENT PRESENT NOT OUTSIDE AS REPORTED IN THE PREVIOUS REPORT. 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 OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SHORT SPINOUS PROCESS CLAMP WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT THE ISSUE OCCURRED POST-OPERATIVELY AFTER AN UNKNOWN PROCEDURE. A PATIENT WAS INVOLVED BUT PATIENT IMPACT INFORMATION COULD NOT BE OBTAINED. IT WAS REPORTED THAT THE PROCEDURE WAS A NAVIGATED, LONG-SEGMENT POSTERIOR SPINAL FUSION (T9 TO S1) FOR ANKYLOSING SPONDYLITIS. THERE WAS A MINOR DELAY OF ROUGHLY TWO MINUTES DUE TO THE REMOVAL OF THE CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375246 SPINOUS PROCESS CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 9734716 230125 00763000206598

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown