MAZOR X SYSTEM
Report
- Report Number
- 3005075696-2021-00117
- Event Type
- Injury
- Date Received
- October 27, 2021
- Date of Event
- April 18, 2021
- Report Date
- October 27, 2021
- Manufacturer
- MAZOR ROBOTICS LTD
- Product Code
- OLO
- PMA / PMN Number
- K182077
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
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: LEE N, BODDAPATI V, MATHEW J, MARCIANO G, FIELDS M, BUCHANA I, ZUCKERMAN S, PARK P, LEUNG E, LOMBARDI J, LEHMAN R. DOES ROBOT-ASSISTED SPINE SURGERY FOR MULTI-LEVEL LUMBAR FUSION ACHIEVE BETTER PATIENT-REPORTED OUTCOMES THAN FREE-HAND TECHNIQUES? INTERDISCIPLINARY NEUROSURGERY: ADVANCED TECHNIQUES AND CASE MANAGEMENT. 2021. 25. DOI.ORG/10.1016/J.INAT.2021.101214. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ABSTRACT: TO COMPARE THE PATIENT-REPORTED OUTCOMES (PROS) BETWEEN PATIENTS UNDERGOING MULTILEVEL LUMBAR FUSION WITH ROBOT-ASSISTED VS. FREEHAND TECHNIQUES. THIS WAS A SINGLE-INSTITUTION COHORT STUDY OF ADULT PATIENTS (=18 YEARS OLD) UNDERGOING ROBOT-ASSISTED SPINE SURGERY FROM 2016 TO 2018 WITH MINIMUM 2-YEAR FOLLOW-UP. A PROPENSITY-SCORE MATCHING (PSM) ALGORITHM ACCOUNTED FOR SEVERAL PERIOPERATIVE FACTORS. PROS WERE MEASURED USING THE OSWESTRY DISABILITY INDEX (ODI). THE MINIMUM CLINICALLY IMPORTANT DIFFERENCE (MCID) BETWEEN GROUPS WERE ASSESSED AT EACH FOLLOW-UP PERIOD (6-WEEKS/6-MONTHS/1-YEAR/2-YEARS). CHI-SQUARE/FISHER EXACT TEST AND T-TEST/ANOVA WERE USED FOR CATEGORICAL AND CONTINUOUS VARIABLES, RESPECTIVELY. AFTER PSM, A TOTAL OF 70 PATIENTS REMAINED. THE MEAN (STANDARD DEVIATION) CHARLSON COMORBIDITY INDEX WAS 1.4 (1.0) AND 57% OF PATIENTS WERE FEMALE. THE MOST COMMON DIAGNOSES INCLUDED DEGENERATIVE DISC DISEASE (37.1%), DEGENERATIVE SCOLIOSIS (27.1%), AND HIGH GRADE SPONDYLOLISTHESIS (GRADE > 2) (19%), AND THE MEAN NUMBER OF INSTRUMENTED LEVELS WAS 4.6 (4.4). RATES FOR INTRAOPERATIVE/POSTOPERATIVE COMPLICATIONS, AND ANY REOPERATION WITHIN 2 YEARS AFTER SURGERY WERE LOW AND SIMILAR BETWEEN GROUPS. THE BASELINE ODI SCORES WERE SIMILAR BETWEEN FREEHAND (39.1) AND ROBOT-ASSISTED SURGERY (40.5, P-VALUE = 0.736). BY TWO YEARS, SUBSTANTIAL IMPROVEMENTS IN BOTH GROUPS (MEAN ODI-FREEHAND: 4.6, ROBOT-ASSISTED: 1.5; MCID%-FREEHAND: 77.1%, ROBOT ASSISTED: 82.9%) WERE ACHIEVED, BUT NOT SIGNIFICANTLY DIFFERENT (P-VALUE > 0.05). NO DIFFERENCES WERE OBSERVED FOR THE OTHER FOLLOW-UP PERIODS. WHEN COMPARING INDIVIDUAL COMPONENT SCORES, THE ROBOT-ASSISTED GROUP SCORED HIGHER IN ¿LIFTING,¿ ¿SITTING,¿ AND ¿STANDING;¿ HOWEVER, THE MAGNITUDES OF THESE DIFFERENCES WERE LESS THAN 1 POINT. ROBOT-ASSISTED MULTI-LEVEL LUMBAR FUSION CAN ACHIEVE EXCELLENT AND SIMILAR PATIENT-REPORTED OUTCOMES TO CONVENTIONAL FREEHAND TECHNIQUES. FUTURE STUDIES SHOULD INCLUDE LARGE, PROSPECTIVE RANDOMIZED CONTROLLED TRIALS AS WELL AS THE INCLUSION OF OTHER PATIENT REPORTED OUTCOME MEASURES. REPORTED EVENTS: AFTER USE OF THE GUIDANCE SYSTEM DURING SPINAL PROCEDURES, ONE PATIENT REQUIRED A REVISION PROCEDURE DUE TO A WOUND COMPLICATION. AFTER USE OF THE GUIDANCE SYSTEM DURING SPINAL PROCEDURES, 10 PATIENTS EXPERIENCED INTRAOPERATIVE DURAL TEARS REQUIRING REPAIR. AFTER USE OF THE GUIDANCE SYSTEM DURING SPINAL PROCEDURES, ONE PATIENT EXPERIENCED INTRAOPERATIVE MOTOR/SENSORY DEFICIT THAT RETURNED TO BASELINE FUNCTION POST OPERATIVELY DURING THE SAME INPATIENT STAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1600196 | MAZOR X SYSTEM | ORTHOPEDIC STEREOTAXIC INSTRUMENT | OLO | MAZOR ROBOTICS LTD | TPL0059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |