Devices › Drills, burrs, trephines & accessories (simple, powered)
Device brand name · Drills burrs trephines & accessories simple
Midas Rex MR8: medical device reports filed with FDA
7,262 reports name it, 2022–2026. Manufacturer given most often on reports: Mdt Powered Surgical Solutions. Product code HBE.
- 7,262
- device reports naming the brand
- 0% of all MAUDE reports · about 1,677 a year
- 6,416
- reports, 12 months to August 2026
- 835 in the 12 months before
- 99.4%
- classified as malfunction
- 96.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 7,262 reports that name the brand "Midas Rex MR8" (drills burrs trephines & accessories simple), received between March 2022 and August 2026; the manufacturer given most often on reports is Mdt Powered Surgical Solutions. Spellings of one product vary from report to report.
6,416 reports arrived in the 12 months to August 2026, up 668% from 835 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 (99.4%) and injury (0.5%); across all drills, burrs, trephines & accessories (simple, powered) reports (product code HBE) death is recorded in 0% and malfunction in 96.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are overheating of device (18.7%), detachment of device or device component (17.4%) and naturally worn (13.9%). The patient problems coded most often are unintended radiation exposure, device embedded in tissue or plaque and burn(s). 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 22,777 reports carrying product code HBE. 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 |
|---|---|---|---|
| Overheating of device | 1,361 | 18.7% | 26.9% |
| Detachment of device or device componentpart of the device came off | 1,263 | 17.4% | 6.6% |
| Naturally worn | 1,011 | 13.9% | 4.5% |
| Difficult to insertthe device was hard to insert | 709 | 9.8% | 3.2% |
| Loss of powerthe device lost power | 312 | 4.3% | 1.5% |
| Difficult to removethe device was hard to remove | 278 | 3.8% | 1.4% |
| Vibration | 227 | 3.1% | 3.5% |
| Fracturea broken bone | 206 | 2.8% | 10.6% |
| Physical resistance/sticking | 162 | 2.2% | 0.9% |
| Noise, audible | 125 | 1.7% | 1.6% |
| Corrodedthe device corroded | 95 | 1.3% | 0.5% |
| Material deformation | 45 | 0.6% | 0.3% |
| Device remains activated | 25 | 0.3% | 0.7% |
| Fluid/blood leak | 24 | 0.3% | 1.1% |
| Material integrity problema problem with the device material | 24 | 0.3% | 0.2% |
| Material twisted/bent | 24 | 0.3% | 0.5% |
| Loose or intermittent connection | 18 | 0.2% | 0.2% |
| Insufficient device problem information | 16 | 0.2% | 0.2% |
| Material puncture/hole | 14 | 0.2% | 0.1% |
| Device displays incorrect message | 12 | 0.2% | 1.3% |
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 |
|---|---|---|
| Unintended radiation exposure | 14 | 0.2% |
| Device embedded in tissue or plaque | 13 | 0.2% |
| Burn(s)a burn | 5 | 0.1% |
| Dural tear | 3 | 0% |
| Painpain, site not specified | 3 | 0% |
| Hemorrhage/blood loss/bleeding | 2 | 0% |
| Partial thickness (second degree) burn | 2 | 0% |
| Alteration in body temperature | 1 | 0% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0% |
| Bruise/contusion | 1 | 0% |
| Chemical exposure | 1 | 0% |
| Convulsion/seizure | 1 | 0% |
| Foreign body in patientpart of a device left in the patient | 1 | 0% |
| Paresthesia | 1 | 0% |
| Perforation | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Midas Rex MR8 | Product code HBE | All MAUDE reports |
|---|---|---|---|
| Reports | 7,262 | 22,777 | 26,136,888 |
| Share of that pool | — | 31.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.5% | 3.1% | 36.2% |
| Classified as malfunction | 99.4% | 96.7% | 62.3% |
| Filed by the manufacturer | 99.8% | 99% | 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 HBE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown_InstrumentstIre_Product | 1,475 | 123 | 0% |
| Micro Sagittal Saw | 1,395 | 0 | 0% |
| Ipc Handpiece - Indigo Drill | 727 | 79 | 0% |
| Perforator Driver W/Hudson End | 695 | 0 | 0% |
| Minimal Access Attachment | 498 | 1 | 0% |
| Motor Legend Ehs Stylus | 417 | 7 | 0% |
| Ipc Handpiece Attachment - Indigo Drill | 391 | 32 | 0% |
| Midas Rex Legend | 952 | 356 | 0% |
| Ipc Handpiece - Stylus Touch | 285 | 6 | 0% |
| Ipc Handpiece - Powerease Driver | 260 | 154 | 0% |
| Footed Attachment 16mm | 256 | 18 | 0% |
| Compact Speed Reducer 60 1 | 325 | 0 | 0% |
| Elite 12cm Straight Attachment | 236 | 12 | 0% |
| Emax 2 Plus Motor | 8,860 | 62 | 0% |
| Core Micro Drill | 670 | 0 | 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 Midas Rex MR8 reports
How many FDA reports name Midas Rex MR8?
7,262 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 6,416 in the latest 12 months.
What kinds of events are reported?
malfunction (99.4%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
overheating of device (18.7%), detachment of device or device component (17.4%), naturally worn (13.9%), difficult to insert (9.8%) and loss of power (4.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Midas Rex MR8 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.