BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAISSANCE SYSTEM

    MDR report key: 13616436 · Received February 28, 2022

    Report

    Report Number
    3005075696-2022-00018
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    December 1, 2021
    Report Date
    February 28, 2022
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    HAW
    PMA / PMN Number
    K152041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: GOOD C, OROSZ L, SCHROERLUCKE S, CANNESTRA A, LIM J, HSU V, ZAHRAWI F, VILLALOBOS H, RAMIREZ P, SWEENEY T, WANG M. COMPLICATIONS AND REVISION RATES IN MINIMALLY INVASIVE ROBOTIC-GUIDED VERSUS FLUOROSCOPIC-GUIDED SPINAL FUSIONS: THE MIS REFRESH PROSPECTIVE COMPARATIVE STUDY. SPINE AN INTERNATIONAL JOURNAL FOR THE STUDY OF THE SPINE. 2021. 46(23):1661-1668. DOI: 10.1097/BRS.0000000000004048. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ABSTRACT: ASSESS RATES OF COMPLICATIONS, REVISION SURGERY, AND RADIATION BETWEEN MAZOR ROBOTIC-GUIDANCE (RG) AND FLUORO-GUIDANCE (FG). MIS REFRESH IS THE FIRST STUDY DESIGNED TO COMPARE RG AND FG TECHNIQUES IN ADULT MIS LUMBAR FUSIONS. PRIMARY ENDPOINTS WERE ANALYZED AT 1 YEAR FOLLOW-UP. ANALYSIS OF VARIABLES THROUGH COX LOGISTIC REGRESSION AND A KAPLAN-MEIER SURVIVAL CURVE OF SURGICAL COMPLICATIONS. 9 SITES ENROLLED 485 PATIENTS: 374 (RG ARM) AND 111 (FG ARM). 93.2% OF PATIENTS HAD >1 YEAR F/U. THERE WERE NO DIFFERENCES FOR GENDER, CHARLSON COMORBIDITY INDEX, DIABETES, OR TUMOR. MEAN AGE OF RG PATIENTS WAS 59.0 VS. 62.5 FOR FG (P=0.009) AND BMI WAS 31.2 VS. 28.1 (P=0.001). PERCENTAGE OF SMOKERS WAS ALMOST DOUBLE IN THE RG (15.2% VS. 7.2%, P=.029). SURGICAL TIME WAS SIMILAR (SKIN-TO-S KIN TIME/#SCREWS) AT 24.9 MIN RG AND 22.9 FG (P=0.550). FLUOROSCOPY DURING SURGERY/#SCREWS WAS 15.5 SEC RG VS. 35.4 SEC FG, (15 SEC AVERAGE REDUCTION). FLUOROSCOPY TIME DURING INSTRUMENTATION/#SCREWS WAS 3.6 SECONDS RG VS. 17.8 SECONDS FG SHOWING AN 80% AVERAGE REDUCTION OF FLUORO TIME/SCREW IN RG (P=0.001). WITHIN ONE YEAR FOLLOW-UP, THERE WERE 39 (10.4%) SURGICAL COMPLICATIONS RG VS. 39 (35.1%) FG, AND 8 (2.1%) REVISIONS RG VS. 7 (6.3%) FG. COX REGRESSION ANALYSIS INCLUDING AGE, GENDER, BMI, CCI AND # SCREWS, DEMONSTRATED THAT THE HAZARD RATIO (HR) FOR COMPLICATION WAS 5.8 TIMES HIGHER FG VS. RG (95% CI: 3.5-9.6, P=0.001). HR FOR REVISION SURGERY WAS 11.0 TIMES HIGHER FG VS. RG CASES (95% CI 2.9-41.2, P=0.001). MAZOR ROBOTIC-GUIDANCE WAS FOUND TO HAVE A 5.8 TIMES LOWER RISK OF A SURGICAL COMPLICATION AND 11.0 TIMES LOWER RISK FOR REVISION SURGERY. SURGICAL TIME WAS SIMILAR BETWEEN GROUPS AND ROBOTIC-GUIDANCE REDUCED FLUORO TIME PER SCREW BY 80% (APPROXIMATELY ONE MINUTE/CASE). REPORTED EVENTS: 1 - ONE PATIENT UNDERGOING PLACEMENT OF SCREWS USING THE GUIDANCE SYSTEM EXPERIENCED RADICULOPATHY. A REVISION WAS DONE TO REMOVE THE SCREWS. 2 - TWO PATIENTS UNDERGOING PLACEMENT OF SCREWS USING THE GUIDANCE SYSTEM EXPERIENCED LOW BACK PAIN. REVISIONS WERE DONE TO REMOVE THE SCREWS. 3 - FOUR PATIENTS UNDERGOING PLACEMENT OF SCREWS USING THE GUIDANCE SYSTEM EXPERIENCED RADICULOPATHY, WHICH REQUIRED A REVISION PROCEDURE FOR DECOMPRESSION. 4 - ONE PATIENT UNDERGOING PLACEMENT OF SCREWS USING THE GUIDANCE SYSTEM EXPERIENCED PSEUDARTHROSIS. A REVISION WAS REQUIRED. 5 - 39 PATIENTS UNDERGOING PLACEMENT OF SCREWS USING THE GUIDANCE SYSTEM EXPERIENCED SURGICAL COMPLICATIONS. 6 - 5 PATIENTS UNDERGOING PLACEMENT OF SCREWS USING THE GUIDANCE SYSTEM EXPERIENCED WOUND COMPLICATIONS. THE WOUNDS WERE TREATED NON-SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172557 RENAISSANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MAZOR ROBOTICS LTD TPL0038

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention