Devices › Orthopedic stereotaxic instrument
Device brand name · Orthopedic stereotaxic instrument
Mazor X System: medical device reports filed with FDA
1,009 reports name it, 2019–2026. Manufacturer given most often on reports: Mazor Robotics. Product code OLO.
- 1,009
- device reports naming the brand
- 0% of all MAUDE reports · about 135 a year
- 238
- reports, 12 months to August 2026
- 393 in the 12 months before
- 81.3%
- classified as malfunction
- 81.6% across the product code
- 0.6%
- classified as death, as reported
- 6 reports · not verified by FDA
FDA's MAUDE database holds 1,009 reports that name the brand "Mazor X System" (orthopedic stereotaxic instrument), received between January 2019 and August 2026; the manufacturer given most often on reports is Mazor Robotics. Spellings of one product vary from report to report.
238 reports arrived in the 12 months to August 2026, down 39% from 393 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (81.3%), injury (18.1%) and death (0.6%); across all orthopedic stereotaxic instrument reports (product code OLO) death is recorded in 0.1% and malfunction in 81.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect, inadequate or imprecise result or readings (47%), imprecision (34.6%) and computer software problem (5.5%). The patient problems coded most often are pain, nerve damage and cerebrospinal fluid leakage. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 20,634 reports carrying product code OLO. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Incorrect, inadequate or imprecise result or readings | 474 | 47% | 4.7% |
| Imprecision | 349 | 34.6% | 3.4% |
| Computer software problema software problem | 55 | 5.5% | 2.7% |
| Mechanical problema mechanical problem | 53 | 5.3% | 9.2% |
| Unintended application program shut down | 29 | 2.9% | 2.4% |
| Communication or transmission problemthe device could not communicate or transmit | 24 | 2.4% | 0.5% |
| Application program freezes or fails to launch | 22 | 2.2% | 0.5% |
| Insufficient device problem information | 20 | 2% | 4.4% |
| Unintended movement | 15 | 1.5% | 1.9% |
| Data problem | 10 | 1% | 0.1% |
| Unintended collision | 10 | 1% | 0.1% |
| Connection problema connection problem | 5 | 0.5% | 2.4% |
| Display or visual feedback problem | 5 | 0.5% | 0.6% |
| Failure to advance | 5 | 0.5% | 0% |
| Malposition of device | 3 | 0.3% | 2% |
| Unstable | 3 | 0.3% | 0.4% |
| Calibration problem | 2 | 0.2% | 0.2% |
| Electrical /electronic property probleman electrical or electronic problem | 2 | 0.2% | 0.5% |
| Manufacturing, packaging or shipping problem | 2 | 0.2% | 0.1% |
| Biocompatibility | 1 | 0.1% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 38 | 3.8% |
| Nerve damage | 28 | 2.8% |
| Cerebrospinal fluid leakage | 25 | 2.5% |
| Post operative wound infection | 24 | 2.4% |
| Muscle weakness/atrophy | 21 | 2.1% |
| Hemorrhage/blood loss/bleeding | 13 | 1.3% |
| Numbnessnumbness | 12 | 1.2% |
| Dural tear | 10 | 1% |
| Paralysis | 9 | 0.9% |
| Hematomaa collection of blood under the skin or in tissue | 8 | 0.8% |
| Ambulation or postural difficulties | 7 | 0.7% |
| Bacterial infectiona bacterial infection | 7 | 0.7% |
| Bone fracture(s) | 5 | 0.5% |
| Erosion | 5 | 0.5% |
| Iatrogenic source | 4 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Mazor X System | Product code OLO | All MAUDE reports |
|---|---|---|---|
| Reports | 1,009 | 20,634 | 26,136,888 |
| Share of that pool | — | 4.9% | 0% |
| Classified as death, per 1,000 reports | 6 | 1 | 9 |
| Classified as injury | 18.1% | 18.2% | 36.2% |
| Classified as malfunction | 81.3% | 81.6% | 62.3% |
| Filed by the manufacturer | 100% | 99.1% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code OLO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Real Intelligence Cori | 983 | 97 | 0% |
| 3 0 Rio Robotic Arm - Mics | 847 | 2 | 0% |
| Handpiece MICS | 812 | 183 | 0% |
| Reamer Handle Offset | 758 | 345 | 0% |
| Velys Saw Interface Right | 611 | 124 | 0% |
| Velys Saw Interface Left | 597 | 125 | 0% |
| Excelsius Gps | 597 | 128 | 0.3% |
| Real Intelligence Robotic Drill | 585 | 81 | 0% |
| Navio Handpiece | 489 | 0 | 0% |
| NavLock | 464 | 90 | 0% |
| Velys Satellite Station | 353 | 94 | 0% |
| Navio Surgical System Us | 334 | 0 | 0% |
| Mako Robotic Arm 3 1 | 317 | 65 | 0% |
| Velys Saw Handpiece | 269 | 82 | 0% |
| Velys | 257 | 257 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Mazor X System reports
How many FDA reports name Mazor X System?
1,009 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 238 in the latest 12 months.
What kinds of events are reported?
malfunction (81.3%), injury (18.1%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect, inadequate or imprecise result or readings (47%), imprecision (34.6%), computer software problem (5.5%), mechanical problem (5.3%) and unintended application program shut down (2.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Mazor X System was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.