Devices › File, pulp canal, endodontic
Device brand name · Dental file
Profile Gt Rotary Instrument: medical device reports filed with FDA
660 reports name it, 2002–2007. Manufacturer given most often on reports: Dentsply Tulsa. Product code EKS.
- 660
- device reports naming the brand
- 0% of all MAUDE reports · about 28 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 95.2%
- classified as malfunction
- 94.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
660 medical device reports received by FDA name the brand "Profile Gt Rotary Instrument" (dental file); the manufacturer given most often on reports is Dentsply Tulsa; received from September 2002 to April 2007. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (95.2%) and injury (4.7%); across all file, pulp canal, endodontic reports (product code EKS) death is recorded in 0% and malfunction in 94.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material separation (93.9%), device, or device fragments remain in patient (38.9%) and break (2.9%). The patient problems coded most often are nonresorbable materials, unretrieved in body, therapy/non-surgical treatment, additional and foreign body, removal of. 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
No report naming Profile Gt Rotary Instrument was received in the five years to August 2026; the latest was received in April 2007.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,963 reports carrying product code EKS. 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 |
|---|---|---|---|
| Material separation | 620 | 93.9% | 22.5% |
| Device, or device fragments remain in patient | 257 | 38.9% | 6.5% |
| Breakthe device broke | 19 | 2.9% | 77.7% |
| Device, removal of (non-implant) | 12 | 1.8% | 0.3% |
| Device or device fragments location unknown | 10 | 1.5% | 0.3% |
| Difficult to removethe device was hard to remove | 5 | 0.8% | 2.7% |
| Tip breakage | 5 | 0.8% | 0.2% |
| Other (for use when an appropriate device code cannot be identified) | 4 | 0.6% | 0.1% |
| Detachment of device component | 3 | 0.5% | 0.5% |
| Replace | 3 | 0.5% | 0.1% |
| Device alarm system | 2 | 0.3% | 0% |
| Bent | 1 | 0.2% | 0% |
| Defective devicethe device was defective | 1 | 0.2% | 0% |
| Failure to calibrate | 1 | 0.2% | 0% |
| Failure to pump | 1 | 0.2% | 0% |
| Filling problem | 1 | 0.2% | 0% |
| Fracturea broken bone | 1 | 0.2% | 0.3% |
| Inadequacy of device shape and/or size | 1 | 0.2% | 0.1% |
| Loose | 1 | 0.2% | 0.1% |
| Malfunction | 1 | 0.2% | 0.1% |
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 |
|---|---|---|
| Nonresorbable materials, unretrieved in body | 254 | 38.5% |
| Therapy/non-surgical treatment, additional | 71 | 10.8% |
| Foreign body, removal of | 38 | 5.8% |
| Surgical procedure, additional | 17 | 2.6% |
| Surgical procedure | 16 | 2.4% |
| Other (for use when an appropriate patient code cannot be identified) | 5 | 0.8% |
| Perforation | 3 | 0.5% |
| Treatment with medication(s) | 3 | 0.5% |
| Device embedded in tissue or plaque | 1 | 0.2% |
| Fistula | 1 | 0.2% |
| Hemolytic anemia | 1 | 0.2% |
| Hospitalization required | 1 | 0.2% |
| Painpain, site not specified | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Profile Gt Rotary Instrument | Product code EKS | All MAUDE reports |
|---|---|---|---|
| Reports | 660 | 3,963 | 26,136,888 |
| Share of that pool | — | 16.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 4.7% | 5.5% | 36.2% |
| Classified as malfunction | 95.2% | 94.4% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 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 EKS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Reciproc Blue Files 6x Sterile | 523 | 42 | 0% |
| Reciproc Files 6x | 307 | 20 | 0% |
| Waveone Gold Reciprocating File Primary 25mm | 163 | 9 | 0% |
| Protaper Nt Rotary File | 171 | 0 | 0% |
| PrimeTaper EV 4.2 x 9mm OS | 1,078 | 519 | 0% |
| Unknown ATIS implant | 830 | 183 | 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 Profile Gt Rotary Instrument reports
How many FDA reports name Profile Gt Rotary Instrument?
660 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (95.2%) and injury (4.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material separation (93.9%), device, or device fragments remain in patient (38.9%), break (2.9%), device, removal of (non-implant) (1.8%) and device or device fragments location unknown (1.5%). 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 Profile Gt Rotary Instrument 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.