Devices › Orthopedic stereotaxic instrument
Device brand name · Orthopedic stereotaxic instrument
NavLock: medical device reports filed with FDA
464 reports name it, 2018–2026. Manufacturer given most often on reports: Medtronic Navigation. Product code OLO.
- 464
- device reports naming the brand
- 0% of all MAUDE reports · about 60 a year
- 90
- reports, 12 months to August 2026
- 149 in the 12 months before
- 97%
- 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 464 reports that name the brand "NavLock" (orthopedic stereotaxic instrument), received between October 2018 and August 2026; the manufacturer given most often on reports is Medtronic Navigation. Spellings of one product vary from report to report.
90 reports arrived in the 12 months to August 2026, down 40% from 149 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 (97%) and injury (3%); 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 mechanical problem (21.6%), material integrity problem (18.5%) and device sensing problem (15.7%). The patient problems coded most often are no patient involvement, device embedded in tissue or plaque and foreign body in patient. 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 |
|---|---|---|---|
| Mechanical problema mechanical problem | 100 | 21.6% | 9.2% |
| Material integrity problema problem with the device material | 86 | 18.5% | 6.2% |
| Device sensing problem | 73 | 15.7% | 0.7% |
| Material fragmentation | 55 | 11.9% | 1.9% |
| Mechanical jam | 48 | 10.3% | 1.6% |
| Imprecision | 35 | 7.5% | 3.4% |
| Incorrect, inadequate or imprecise result or readings | 33 | 7.1% | 4.7% |
| Component missing | 4 | 0.9% | 0.6% |
| Device handling problem | 2 | 0.4% | 0% |
| Human-device interface problem | 2 | 0.4% | 3.3% |
| Breakthe device broke | 1 | 0.2% | 10.3% |
| Communication or transmission problemthe device could not communicate or transmit | 1 | 0.2% | 0.5% |
| Degraded | 1 | 0.2% | 0.2% |
| Dent in material | 1 | 0.2% | 0% |
| Failure to advance | 1 | 0.2% | 0% |
| Mechanics altered | 1 | 0.2% | 0.6% |
| Naturally worn | 1 | 0.2% | 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 |
|---|---|---|
| No patient involvement | 43 | 9.3% |
| Device embedded in tissue or plaque | 8 | 1.7% |
| Foreign body in patientpart of a device left in the patient | 7 | 1.5% |
| Muscle weakness/atrophy | 2 | 0.4% |
| Spinal cord injury | 2 | 0.4% |
| Bone fracture(s) | 1 | 0.2% |
| Cerebrospinal fluid leakage | 1 | 0.2% |
| Dural tear | 1 | 0.2% |
| Fever | 1 | 0.2% |
| Hyperthermia | 1 | 0.2% |
| Paresis | 1 | 0.2% |
| Perforation | 1 | 0.2% |
| Perforation of vessels | 1 | 0.2% |
| Post operative wound infection | 1 | 0.2% |
| Spinal column injury | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | NavLock | Product code OLO | All MAUDE reports |
|---|---|---|---|
| Reports | 464 | 20,634 | 26,136,888 |
| Share of that pool | — | 2.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 3% | 18.2% | 36.2% |
| Classified as malfunction | 97% | 81.6% | 62.3% |
| Filed by the manufacturer | 99.1% | 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% |
| 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 NavLock reports
How many FDA reports name NavLock?
464 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 90 in the latest 12 months.
What kinds of events are reported?
malfunction (97%) and injury (3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
mechanical problem (21.6%), material integrity problem (18.5%), device sensing problem (15.7%), material fragmentation (11.9%) and mechanical jam (10.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.1%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that NavLock 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.