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FDA product code OLO · class 2 · Neurology
Orthopedic stereotaxic instrument: medical device reports filed with FDA
20,634 reports carry this product code, 2008–2026; 30 brands with a page.
- 20,634
- reports with this product code
- 0.1% of all MAUDE reports
- 2,980
- reports, 12 months to August 2026
- 3,292 in the 12 months before
- 81.6%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
Product code OLO is FDA's classification for "Orthopedic stereotaxic instrument" (neurology panel), a class 2 device. 20,634 medical device reports carry this product code, 0.1% of the MAUDE database, from October 2008 to August 2026.
2,980 reports arrived in the 12 months to August 2026, close to the 3,292 of 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 (81.6%), injury (18.2%) and death (0.1%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Mako Surgical | 4,949 | 24% |
| Blue Belt Technologies | 4,502 | 21.8% |
| Medtronic Navigation | 2,546 | 12.3% |
| Depuy Ireland | 1,660 | 8% |
| Mazor Robotics | 1,096 | 5.3% |
| Medtronic Navigation Louisville | 917 | 4.4% |
| Globus Medical | 755 | 3.7% |
| Depuy Spine | 581 | 2.8% |
| Depuy Ireland - 9616671 | 353 | 1.7% |
| Medtronic Sofamor Danek USA | 321 | 1.6% |
| Medos International S Rl Ch | 235 | 1.1% |
| Depuy Orthopaedics | 195 | 0.9% |
| Stryker Instruments-Kalamazoo | 184 | 0.9% |
| Alphatec Spine | 115 | 0.6% |
| Medtech | 108 | 0.5% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Breakthe device broke | 2,118 | 10.3% |
| Mechanical problema mechanical problem | 1,898 | 9.2% |
| Detachment of device or device componentpart of the device came off | 1,486 | 7.2% |
| Device slipped | 1,475 | 7.1% |
| Material integrity problema problem with the device material | 1,283 | 6.2% |
| Incorrect, inadequate or imprecise result or readings | 968 | 4.7% |
| Insufficient device problem information | 916 | 4.4% |
| Material deformation | 848 | 4.1% |
| Imprecision | 698 | 3.4% |
| Human-device interface problem | 679 | 3.3% |
| Fracturea broken bone | 646 | 3.1% |
| Application program problem: parameter calculation error | 595 | 2.9% |
| Computer software problema software problem | 560 | 2.7% |
| Unintended application program shut down | 502 | 2.4% |
| Connection problema connection problem | 497 | 2.4% |
| Non reproducible results | 436 | 2.1% |
| Malposition of device | 408 | 2% |
| Unintended movement | 401 | 1.9% |
| Device-device incompatibility | 387 | 1.9% |
| Material fragmentation | 384 | 1.9% |
Questions about orthopedic stereotaxic instrument reports
What is product code OLO?
FDA's classification code for "Orthopedic stereotaxic instrument", class 2, reviewed by the neurology panel. Every device report carries the product code of the device involved.
How many reports carry this code?
20,634 reports through August 2026, 2,980 of them in the latest 12 months.
Which brands appear most often?
Mazor X System (1,004), Real Intelligence Cori (982), 3 0 Rio Robotic Arm - Mics (846), Handpiece MICS (812) and Reamer Handle Offset (758). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.