BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINEASSIST SYSTEM

    MDR report key: 8905972 · Received August 19, 2019

    Report

    Report Number
    1723170-2019-04522
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    October 22, 2009
    Report Date
    August 19, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K073467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. THE REPORTED EVENT WAS FROM THE FOLLOWING LITERATURE ARTICLE: DEVITO D, KAPLAN L, DIETL R, PFEIFFER M, HORNE D, SILBERSTEIN B, HARDENBROOK M, KIRIYANTHAN G, BARZILAY Y, BRUSKIN A, SACKERER D, AL EXANDROVSKY V, STUER C, BURGER R, MAEURER J, GORDON D, ET AL. CLINICAL ACCEPTANCE AND ACCURACY ASSESSMENT OF SPINAL IMPLANTS GUIDED WITH SPINE ASSIST SURGICAL ROBOT: RETROSPECTIVE STUDY. SPINE. 2010. VOLUME 35, NUMBER 24, PP 2109-2115. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    ABSTRACT: RETROSPECTIVE, MULTICENTER STUDY OF ROBOTICALLY-GUIDED SPINAL IMPLANT INSERTIONS. CLINICAL ACCEPTANCE OF THE IMPLANTS WAS ASSESSED BY INTRAOPERATIVE RADIOGRAPH, AND WHEN AVAILABLE, POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCANS WERE USED TO DETERMINE PLACEMENT ACCURACY. TO VERIFY THE CLINICAL ACCEPTANCE AND ACCURACY OF ROBOTICALLY-GUIDED SPINAL IMPLANTS AND COMPARE TO THOSE OF UNGUIDED FREE-HAND PROCEDURES. SUMMARY OF BACKGROUND DATA. SPINE ASSIST SURGICAL ROBOT HAS BEEN USED TO GUIDE IMPLANTS AND GUIDE-WIRES TO PREDEFINED LOCATIONS IN THE SPINE. SPINE ASSIST WHICH, TO THE BEST OF THE AUTHORS¿ KNOWLEDGE, IS CURRENTLY THE SOLE ROBOT PROVIDING SURGICAL ASSISTANCE IN POSITIONING TOOLS IN THE SPINE, GUIDED OVER 840 CASES IN 14 HOSPITALS, BETWEEN JUNE 2005 AND JUNE 2009. CLINICAL ACCEPTANCE OF 3271 PEDICLE SCREWS AND GUIDE-WIRES INSERTED IN 635 REPORTED CASES WAS ASSESSED BY INTRAOPERATIVE FLUOROSCOPY, WHERE PLACEMENT ACCURACY OF 646 PEDICLE SCREWS INSERTED IN 139 PATIENTS WAS MEASURED USING POSTOPERATIVE CT SCANS. SCREW PLACEMENTS WERE FOUND TO BE CLINICALLY ACCEPTABLE IN 98% OF THE CASES WHEN INTRAOPERATIVELY ASSESSED BY FLUOROSCOPIC IMAGES. MEASUREMENTS DERIVED F ROM POSTOPERATIVE CT SCANS DEMONSTRATED THAT 98.3% OF THE SCREWS FELL WITHIN THE SAFE ZONE, WHERE 89.3% WERE COMPLETELY WITHIN THE PEDICLE AND 9% BREACHED THE PEDICLE BY UP TO 2 MM. THE REMAINING 1.4% OF THE SCREWS BREACHED BETWEEN 2 AND 4 MM, WHILE ONLY 2 SCREWS (0.3%) DEVIATED BY MORE THAN 4 MM FROM THE PEDICLE WALL. NEUROLOGICAL DEFICITS WERE OBSERVED IN 4 CASES YET, FOLLOWING REVISIONS, NO PERMANENT NERVE DAMAGE WAS ENCOUNTERED, IN CONTRAST TO THE 0.6% TO 5% OF NEUROLOGICAL DAMAGE REPORTED IN THE LITERATURE. SPINE ASSIST OFFERS ENHANCED PERFORMANCE IN SPINAL SURGERY WHEN COMPARED TO FREE-HAND SURGERIES, BY INCREASING PLACEMENT ACCURACY AND REDUCING NEUROLOGICAL RISKS. IN ADDITION, 49% OF THE CASES REPORTED HEREIN USED A PERCUTANEOUS APPROACH, HIGHLIGHTING THE CONTRIBUTION OF SPINE ASSIST IN PROCEDURES WITHOUT ANATOMIC LANDMARKS. REPORTED EVENTS: 1. 4 PATIENTS OPERATED ON USING THE GUIDANCE SYSTEM EXPERIENCED REVERSIBLE NEUROLOGICAL DEFICITS. NONE OF THE PATIENTS EXPERIENCED PERMANENT NEUROLOGICAL DEFICIT ONCE A REVISION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699202 SPINEASSIST SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC TPL0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention