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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAZOR ROBOTICS LTD MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAZOR ROBOTICS LTD MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TPL0059
Device Problems Imprecision (1307); Use of Device Problem (1670)
Patient Problems Tissue Breakdown (2681); Insufficient Information (4580)
Event Date 05/12/2021
Event Type  Injury  
Manufacturer Narrative
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, buchanan i, boddapati v, mathew j, marciano g, park p, leung e, buchholz a, pollina j, jazini e, haines c, schuler t, good c, lombardi j, lehman r. Do robot-related complications influence year reoperations and other clinical outcomes after robot-assisted lumbar arthrodesis? a multicenter assessment of 320 patients. Journal of orthopaedic surgery and research. (2021) 16:308. Https://doi. Org/10. 1186/s13018-021-02452-z if information is provided in the future, a supplemental report will be issued.
 
Event Description
Abstract: robot-assisted platforms in spine surgery have rapidly developed into an attractive technology for both the surgeon and patient. Although current literature is promising, more clinical data is needed. The purpose of this paper is to determine the effect of robot-related complications on clinical outcomes this multicenter study included adult (
=
18 years old) patients who underwent robot-assisted lumbar fusion surgery from 2012-2019. The minimum follow-up was 1 year after surgery. Both bivariate and multivariate analyses were performed to determine if robot-related factors were associated with reoperation within 1 year after primary surgery. A total of 320 patients were included in this study. The mean (standard deviation) charlson comorbidity index was 1. 2 (1. 2) and 52. 5% of patients were female. Intraoperative robot complications occurred in 3. 4% of patients and included intraoperative exchange of screw (0. 9%), robot abandonment (2. 5%), and return to the operating room for screw exchange (1. 3%). The 1-year reoperation rate was 4. 4%. Robot factors, including robot time per screw, open vs. Percutaneous, and robot system, were not statistically different between those who required revision surgery and those who did not (p>0. 05). Patients with robot complications were more likely to have prolonged length of hospital stay and blood transfusion, but were not at higher risk for 1-year reoperations. The most common reasons for reoperation were wound complications (2. 2%) and persistent symptoms due to inadequate decompression (1. 5%). In the multivariate analysis, robot related factors and complications were not independent risk factors for 1-year reoperations. Reported events: one patient undergoing lumbar arthrodesis using the guidance system required a revision for screw removal and/or exchange. There was no injury to motor/sensory function. Four patients undergoing lumbar arthrodesis using the guidance system required a revision during the initial hospital stay for screw removal and/or exchange. There was no injury to motor/sensory function. After use of the guidance system for lumbar arthrodesis, six patient experienced wound complications within 90 days after the surgery. A revision procedure was required. After use of the guidance system for lumbar arthrodesis, one patient experienced a wound complication between 91 days and a year after surgery. A revision procedure was required. During use of the guidance system for lumbar arthrodesis, malpositioned screws were repositioned during three procedures. There was no injury to motor/sensory function.
 
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Brand NameMAZOR X SYSTEM
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
IS 3079567
Manufacturer (Section G)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
IS 3079567
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13615023
MDR Text Key288397408
Report Number3005075696-2022-00014
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180307
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTPL0059
Device Catalogue NumberTPL0059
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/27/2022 Patient Sequence Number: 1
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