BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP

    MDR report key: 23115655 · Received September 22, 2025

    Report

    Report Number
    1723170-2025-03295
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 26, 2024
    Report Date
    September 22, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    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

    H3, H6: THE SPINE CLAMP, LOT NUMBER: 230227, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE SCREW HOLE OF THE SPINE CLAMP WAS FOUND TO BE PARTIALLY STRIPPED THAT WOULD MAKE IT DIFFICULT TO TIGHTENED. THE REPORTED EVENT COULD BE DUPLICATED BY MEDTRONIC PERSONNEL. 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.

    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 THE SCREW HOLE OF THE OPEN SPINE CLAMP WAS STRIPPED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218672 OPEN SPINE CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 9731780 230227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown