BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONPOINT SURGICAL SYSTEM

    MDR report key: 22991824 · Received September 8, 2025

    Report

    Report Number
    3016534677-2025-00001
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    August 4, 2025
    Report Date
    September 4, 2025
    Manufacturer
    ONPOINT SURGICAL, INC.
    Product Code
    SBF
    PMA / PMN Number
    K241870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONPOINT CLINICAL STAFF WAS PRESENT DURING THE SURGERY AND WITNESSED A DISCREPANCY BETWEEN NAVIGATED INSTRUMENTS IN USE WHILE THE SURGEON WAS PREPARING PLACEMENT OF THE PEDICLE SCREWS. INSTRUMENTS HAD BEEN CALIBRATED INCORRECTLY, RECALIBRATION WAS NOT PERFORMED. THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE ONPOINT SURGICAL SYSTEM. ONPOINT SURGICAL HAS TAKEN USER ERROR INTO CONSIDERATION, HOWEVER THERE WILL ALWAYS BE RESIDUAL RISKS RELATED TO THE USER THAT CANNOT BE COMPLETELY MITIGATED. THERE WAS NO NEGATIVE EFFECT DUE TO THE PROLONGED USE OF ANESTHESIA BY APPROXIMATELY 30 MINUTES. THE PATIENT HAD A WEAKNESS IN THE RIGHT FOOT, AFTER THE SURGERY. THERE WERE NO FURTHER REMEDIAL ACTIONS NECESSARY, DONE, OR PLANNED FOR THIS PATIENT.

    Description of Event or Problem · 0

    AN MIS SURGERY ON THE LUMBAR SPINE WITH FUSION OF AND SCREW PLACEMENT IN VERTEBRAE L4 AND L5 (4 PEDICLE SCREWS TOTAL) WAS PERFORMED WITH THE AID OF THE ONPOINT SPINE SYSTEM. PATIENT WAS POSITIONED PRONE ON THE OPERATING ROOM TABLE. SURGEON ATTACHED THE NAVIGATION REFERENCE ARRAY WITH IMAGING PHANTOM TO THE PELVIS. INTRAOPERATIVE 3D CONE BEAM CT SCAN WAS PERFORMED USING AN O-ARM. SURGEON VERIFIED THE AUTOMATIC REGISTRATION OF THE SCAN TO THE PATIENT ANATOMY AND JUDGED THE ACCURACY OF THE REGISTRATION TO BE GOOD. TAP, DRIVER, POINTER AND UNIVERSAL DRILL GUIDE WERE CALIBRATED. SURGEON PLANNED INCISION WITH POINTER. PREPARED 2 SCREW CANALS IN L4 AND L5 USING THE DRILL GUIDE FIRST ON THE LEFT SIDE, PLACED GUIDE WIRES INTO EACH CANAL, THEN TAPPED AND PLACED SCREWS OVER THE GUIDEWIRES WITH NAVIGATION. ONPOINT CLINICAL STAFF OBSERVED AND POINTED OUT AN INSTRUMENT CALIBRATION ERROR, BUT INSTRUMENTS WERE NOT RECALIBRATED. THE PLANNED SCREW PLACEMENT WAS PERFORMED ON THE LEFT SIDE. SURGEON THEN MOVED TO THE RIGHT SIDE. PREPARED 2 CANALS ON L4 AND L5 USING THE DRILL GUIDE, PLACED 2 GUIDE WIRES INTO THE PREPARED CANALS. PLACED A NAVIGATED TAP OVER THE GUIDEWIRES INTO THE PREPARED CANALS. PLACED 2 SCREWS USING THE DRIVER OVER THE GUIDEWIRES INTO THE PREPARED CANALS. SURGEON OBTAINED INTRAOPERATIVE FLUOROSCOPY IMAGES AND DETERMINED THAT 3 SCREWS IN L4 AND L5 WERE NOT PLACED AS INTENDED. REMOVED 3 OF THE 4 SCREWS AND REPLACED THEM USING CONVENTIONAL METHODS, WITHOUT THE AID OF NAVIGATION. THE 4TH SCREW WAS JUDGED TO BE ACCEPTABLE AT THIS TIME. THE SURGERY ENDED WITH A PROLONGATION OF ANESTHESIA OF APPROXIMATELY 30 MINUTES (WITH NO NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THIS PROLONGATION). SURGEON ORDERED A POST OPERATIVE CT SCAN. THE 4TH SCREW WAS JUDGED TO BE INFERIOR FROM ITS INTENDED POSITION SO THE PATIENT WAS RETURNED TO THE OR TO REPLACE THE SCREW. THE PATIENT HAD A NEUROLOGICAL DEFICIT AFTER THE SURGERY, WITH WEAKNESS IN THE RIGHT FOOT. ACCORDING TO THE SURGEON, THE FINAL SCREW PLACEMENTS WERE CORRECT AS INTENDED. THERE WERE NO FURTHER REMEDIAL ACTIONS NECESSARY, DONE, OR PLANNED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067312 ONPOINT SURGICAL SYSTEM ORTHOPEDIC AUGMENTED REALITY SBF ONPOINT SURGICAL, INC. NK0210101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention