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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 10/01/2021
Event Type  Injury  
Event Description
Abstract: multiple-rod constructs (mrcs) are often used in deformity correction for increased stability and rigidity. There are currently no reports showing minimally invasive placement of mrcs in adult deformity surgery and its technical feasibility through preoperative software planning. Data were collected retrospectively from medical records of six consecutive patients who underwent minimally invasive mrcs with robotics planning by a single surgeon at an academic center between march¿august 2020. A total of six patients (4 females, mean age 69. 7 years) underwent minimally invasive long-segment (6 +) posterior fixation with multiple rods (3 +) using the mazor x stealth edition robotics platform. Average follow-up was 14. 3 months. All patients underwent oblique lumbar interbody fusion (olif) as a first stage, followed by second stage posterior fixation in the same day. The mean number of levels posteriorly instrumented was 8. 8. One patient underwent 3 rod fixation (1 iliac, 2 s2ai) and 5 patients underwent quad rod fixation (2 iliac, 2 s2ai). The mean time to secure all rods was 8 min 36 s. Mean improvement in spinopelvic parameters was -4. 9 cm sagittal vertical axis, 18. 0° lum bar lordosis, and -10. 7° pelvic tilt with an average pelvic incidence of 62. 5°. Estimated blood loss (ebl) was 100¿250 cc with no blood transfusions, and all but one patient ambulated on postoperative day 1 or 2. Spinal robotics brings us into a new era of minimally invasive construct design. To our knowledge, this is the first description of the technical feasibility of mrcs in minimally invasive adult spinal deformity surgery. Reported events 1. After use of the guidance system for spinal surgery to place screws, one patient required a revision for a wound infection related to the olif approach.
 
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: pham m, shah v, diaz-aguilar l, osorio j, lehman r. Minimally invasive multiple-rod constructs with robotics planning in adult spinal deformity surgery: a case series. European spine journal. 2021. Https://doi. Org/10. 1007/s00586-021-06980-4. If information is provided in the future, a supplemental report will be issued.
 
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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 Key13003869
MDR Text Key286868172
Report Number3005075696-2021-00137
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182077
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 12/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTPL0059
Device Catalogue NumberTPL0059
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/27/2021
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: 12/14/2021 Patient Sequence Number: 1
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