Devices › Implant, endosseous, root-form
Device brand name · Endosseous dental implant
Nobel Biocare N1 TiUltra TCC RP 4.0x11mm: medical device reports filed with FDA
1,596 reports name it, 2021–2026. Manufacturer given most often on reports: Nobel Biocare. Product code DZE.
- 1,596
- device reports naming the brand
- 0% of all MAUDE reports · about 331 a year
- 418
- reports, 12 months to August 2026
- 365 in the 12 months before
- 1.1%
- classified as malfunction
- 0.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,596 reports that name the brand "Nobel Biocare N1 TiUltra TCC RP 4.0x11mm" (endosseous dental implant), received between September 2021 and August 2026; the manufacturer given most often on reports is Nobel Biocare. Spellings of one product vary from report to report.
418 reports arrived in the 12 months to August 2026, up 15% from 365 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 injury (98.9%) and malfunction (1.1%); across all implant, endosseous, root-form reports (product code DZE) death is recorded in 0% and malfunction in 0.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to osseointegrate (67.9%), loss of osseointegration (16.3%) and osseointegration problem (6.5%). The patient problems coded most often are failure of implant, pain and inflammation. 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 3,924,241 reports carrying product code DZE. 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 |
|---|---|---|---|
| Failure to osseointegrate | 1,084 | 67.9% | 62.8% |
| Loss of osseointegration | 260 | 16.3% | 22.4% |
| Osseointegration problem | 104 | 6.5% | 7.7% |
| Insufficient device problem information | 14 | 0.9% | 0.2% |
| Difficult to insertthe device was hard to insert | 12 | 0.8% | 0.4% |
| Patient device interaction problem | 12 | 0.8% | 0.3% |
| Difficult to removethe device was hard to remove | 10 | 0.6% | 0% |
| Material deformation | 10 | 0.6% | 0.1% |
| Migrationthe device moved from where it was placed | 10 | 0.6% | 0.1% |
| Premature separation | 10 | 0.6% | 0.1% |
| Device markings/labelling problema problem with the device markings or label | 4 | 0.3% | 0% |
| Fracturea broken bone | 4 | 0.3% | 1.6% |
| Separation failure | 4 | 0.3% | 0.1% |
| Activation, positioning or separation problem | 2 | 0.1% | 0% |
| Labelling, instructions for use or training problem | 2 | 0.1% | 0% |
| Malposition of device | 2 | 0.1% | 0.1% |
| Mechanical problema mechanical problem | 2 | 0.1% | 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 |
|---|---|---|
| Failure of implant | 1,001 | 62.7% |
| Painpain, site not specified | 76 | 4.8% |
| Inflammationinflammation | 26 | 1.6% |
| Fistula | 24 | 1.5% |
| Implant pain | 24 | 1.5% |
| Numbnessnumbness | 20 | 1.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 16 | 1% |
| Abscessa collection of pus | 14 | 0.9% |
| Bone fracture(s) | 10 | 0.6% |
| Hypersensitivity/allergic reaction | 4 | 0.3% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.1% |
| Sinus perforation | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Nobel Biocare N1 TiUltra TCC RP 4.0x11mm | Product code DZE | All MAUDE reports |
|---|---|---|---|
| Reports | 1,596 | 3,924,241 | 26,136,888 |
| Share of that pool | — | 0% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 98.9% | 99.2% | 36.2% |
| Classified as malfunction | 1.1% | 0.8% | 62.3% |
| Filed by the manufacturer | 49.9% | 77.7% | 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 DZE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Biohorizons Dental Implant | 58,732 | 0 | 0% |
| BioHorizons Inc. | 57,020 | 25,536 | 0% |
| NobelActive Internal RP 4.3x10mm | 49,098 | 9,528 | 0% |
| BLT ?4.1mm RC, SLA? 10mm, TiZr, Loxim | 45,650 | 9,677 | 0% |
| NobelParallel CC RP 4.3x10mm | 44,269 | 9,318 | 0% |
| BLT ?4.1mm RC, SLActive? 10mm, TiZr, NTP | 41,672 | 7,531 | 0% |
| Unknown Implant | 39,967 | 1,454 | 0% |
| NobelReplace CC RP 4.3x10mm | 35,946 | 8,166 | 0% |
| NobelReplace CC PMC RP 4.3x10mm | 34,447 | 8,690 | 0% |
| NobelActive Internal RP 4.3x11.5mm | 33,117 | 5,704 | 0% |
| BLT ?3.3mm NC, SLA? 10mm, TiZr, Loxim | 28,648 | 5,695 | 0% |
| BLT ?4.1mm RC, SLA? 10mm, Ti, Loxim | 26,724 | 8,481 | 0% |
| BLT ?3.3mm NC, SLActive? 10mm, TiZr, NTP | 26,540 | 4,680 | 0% |
| NobelActive Internal RP 4.3x13mm | 25,556 | 3,764 | 0% |
| BLT ?4.1mm RC, SLA? 8mm, TiZr, Loxim | 24,772 | 5,978 | 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 Nobel Biocare N1 TiUltra TCC RP 4.0x11mm reports
How many FDA reports name Nobel Biocare N1 TiUltra TCC RP 4.0x11mm?
1,596 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 418 in the latest 12 months.
What kinds of events are reported?
injury (98.9%) and malfunction (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to osseointegrate (67.9%), loss of osseointegration (16.3%), osseointegration problem (6.5%), insufficient device problem information (0.9%) and difficult to insert (0.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
distributor reports (50.1%) and manufacturer reports (49.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Nobel Biocare N1 TiUltra TCC RP 4.0x11mm 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.