Devices › Orthopedic stereotaxic instrument
Device brand name · Orthopedic stereotaxic instrument
Mako Robotic Arm 3 1: medical device reports filed with FDA
317 reports name it, 2020–2026. Manufacturer given most often on reports: Mako Surgical. Product code OLO.
- 317
- device reports naming the brand
- 0% of all MAUDE reports · about 49 a year
- 65
- reports, 12 months to August 2026
- 84 in the 12 months before
- 83.3%
- classified as malfunction
- 81.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 317 reports that name the brand "Mako Robotic Arm 3 1" (orthopedic stereotaxic instrument), received between February 2020 and August 2026; the manufacturer given most often on reports is Mako Surgical. Spellings of one product vary from report to report.
65 reports arrived in the 12 months to August 2026, down 23% from 84 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 (83.3%) and injury (16.7%); 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 (57.4%), application program problem: parameter calculation error (17.7%) and positioning problem (15.5%). The patient problems coded most often are muscle/tendon damage, bone fracture(s) and joint dislocation. 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 | 182 | 57.4% | 4.7% |
| Application program problem: parameter calculation error | 56 | 17.7% | 2.9% |
| Positioning problem | 49 | 15.5% | 1.1% |
| Unintended movement | 49 | 15.5% | 1.9% |
| Positioning failure | 33 | 10.4% | 0.8% |
| No visual prompts/feedback | 20 | 6.3% | 0.2% |
| Failure to calibrate | 16 | 5% | 0.7% |
| Malposition of device | 15 | 4.7% | 2% |
| Insufficient device problem information | 11 | 3.5% | 4.4% |
| Unintended system motionthe device moved when it should not have | 10 | 3.2% | 0.4% |
| Inappropriate tactile prompt/feedback | 8 | 2.5% | 0.2% |
| Mechanical problema mechanical problem | 8 | 2.5% | 9.2% |
| Output problem | 6 | 1.9% | 1.4% |
| Noise, audible | 5 | 1.6% | 0.4% |
| Failure to align | 4 | 1.3% | 0.1% |
| Computer software problema software problem | 3 | 0.9% | 2.7% |
| Fracturea broken bone | 3 | 0.9% | 3.1% |
| Loss of osseointegration | 3 | 0.9% | 0.1% |
| Application program freezes or fails to launch | 2 | 0.6% | 0.5% |
| Calibration problem | 2 | 0.6% | 0.2% |
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 |
|---|---|---|
| Muscle/tendon damage | 9 | 2.8% |
| Bone fracture(s) | 6 | 1.9% |
| Joint dislocationa dislocated joint | 4 | 1.3% |
| Laceration(s) | 4 | 1.3% |
| Painpain, site not specified | 4 | 1.3% |
| Ambulation or postural difficulties | 3 | 0.9% |
| Damage to ligament(s) | 3 | 0.9% |
| Inadequate osseointegration | 3 | 0.9% |
| Injurya physical injury | 3 | 0.9% |
| Deformity/ disfigurement | 2 | 0.6% |
| Joint laxity | 2 | 0.6% |
| Unequal limb length | 2 | 0.6% |
| Administration site reaction | 1 | 0.3% |
| Aneurysm | 1 | 0.3% |
| Hip fracturea broken hip | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Mako Robotic Arm 3 1 | Product code OLO | All MAUDE reports |
|---|---|---|---|
| Reports | 317 | 20,634 | 26,136,888 |
| Share of that pool | — | 1.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 16.7% | 18.2% | 36.2% |
| Classified as malfunction | 83.3% | 81.6% | 62.3% |
| Filed by the manufacturer | 99.7% | 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 |
|---|---|---|---|
| Mazor X System | 1,009 | 238 | 0.6% |
| 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% |
| 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 Mako Robotic Arm 3 1 reports
How many FDA reports name Mako Robotic Arm 3 1?
317 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 65 in the latest 12 months.
What kinds of events are reported?
malfunction (83.3%) and injury (16.7%). "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 (57.4%), application program problem: parameter calculation error (17.7%), positioning problem (15.5%), unintended movement (15.5%) and positioning failure (10.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Mako Robotic Arm 3 1 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.