BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIJOINT NAVIGATION SYSTEM

    MDR report key: 23256122 · Received October 9, 2025

    Report

    Report Number
    3010822102-2025-00001
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 6, 2025
    Manufacturer
    INTELLIJOINT SURGICAL INC.
    Product Code
    OLO
    PMA / PMN Number
    K191507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTELLIJOINT SURGICAL RECEIVED A REPORT INDICATING THAT THE PELVIC SCREW SKIVED OFF THE ILLIAC CREST DURING INSTALLATION AND RESULTED IN A BOWEL PUNCTURE. ADDITIONAL INFORMATION OBTAINED FROM THE COMPLAINANT INDICATED THAT THE SURGEON USED THEIR OWN SURGICAL TECHNIQUE FOR INSTALLATION OF THE PELVIC SCREW INSTEAD OF THE TECHNIQUE IN THE USER MANUAL. INFORMATION RELATED TO THE DEVICE (LOT NUMBER/SERIAL NUMBER) WERE NOT AVAILABLE AND THE DEVICE COULD BE RETURNED FOR EVALUATION. A REVIEW OF HISTORICAL COMPLAINTS FOR THE PRODUCT REVEALED NO SIMILAR COMPLAINTS. THE REPORTED EVENT IS A KNOWN RISK THAT WAS PREVIOUSLY IDENTIFIED THROUGH THE RISK MANAGEMENT PROCESS. EXISTING RISK CONTROL MEASURES ARE IMPLEMENTED AND EFFECTIVE; NO NEW RISKS WERE IDENTIFIED. THE PRODUCT LABELING WAS REVIEWED AND WAS DEEMED APPROPRIATE. THERE IS NO EVIDENCE TO SUGGEST THAT THE INTELLIJOINT NAVIGATION SYSTEM MALFUNCTIONED OR FAILED TO PERFORM AS INTENDED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    USER REPORTED AN INCIDENT WHERE DURING PIN INSTALLATION, ONE OF THE PELVIC PINS SKIVED OFF THE ILIAC CREST. A CT SCAN WAS ORDERED POST-OP WHICH SHOWED A BOWEL PUNCTURE. THE PATIENT UNDERWENT EMERGENCY SURGERY TO REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2646272 INTELLIJOINT NAVIGATION SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO INTELLIJOINT SURGICAL INC. 000-0234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H