Devices › Abutment, implant, dental, endosseous
Device brand name · Bellatek zirconia abutment
Bellatek Zirconia Abutment: medical device reports filed with FDA
222 reports name it, 2013–2017. Manufacturer given most often on reports: Biomet 3i. Product code NHA.
- 222
- device reports naming the brand
- 0% of all MAUDE reports · about 17 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 100%
- classified as malfunction
- 67.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
222 medical device reports received by FDA name the brand "Bellatek Zirconia Abutment" (bellatek zirconia abutment); the manufacturer given most often on reports is Biomet 3i; received from August 2013 to December 2017. 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 (100%); across all abutment, implant, dental, endosseous reports (product code NHA) death is recorded in 0% and malfunction in 67.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fracture (90.5%), nonstandard device (10.4%) and difficult to insert (7.7%). The patient problems coded most often are no patient involvement, tooth fracture and bone fracture(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
No report naming Bellatek Zirconia Abutment was received in the five years to August 2026; the latest was received in December 2017.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 8,582 reports carrying product code NHA. 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 |
|---|---|---|---|
| Fracturea broken bone | 201 | 90.5% | 66.5% |
| Nonstandard device | 23 | 10.4% | 0.4% |
| Difficult to insertthe device was hard to insert | 17 | 7.7% | 0.3% |
| Breakthe device broke | 15 | 6.8% | 2.1% |
| Material fragmentation | 6 | 2.7% | 0.1% |
| Detachment of device or device componentpart of the device came off | 5 | 2.3% | 0.3% |
| Detachment of device component | 3 | 1.4% | 0.1% |
| Loose or intermittent connection | 2 | 0.9% | 0.8% |
| Positioning problem | 2 | 0.9% | 0.6% |
| Connection problema connection problem | 1 | 0.5% | 0.5% |
| Device difficult to setup or prepare | 1 | 0.5% | 0% |
| Device dislodged or dislocated | 1 | 0.5% | 0% |
| Device or device fragments location unknown | 1 | 0.5% | 0% |
| Device slipped | 1 | 0.5% | 0.1% |
| Improper or incorrect procedure or method | 1 | 0.5% | 0% |
| Inadequacy of device shape and/or size | 1 | 0.5% | 0% |
| Loss of or failure to bond | 1 | 0.5% | 0% |
| Material separation | 1 | 0.5% | 0.1% |
| Out-of-box failure | 1 | 0.5% | 0% |
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 | 10 | 4.5% |
| Tooth fracture | 4 | 1.8% |
| Bone fracture(s) | 3 | 1.4% |
| Complaint, ill-defined | 1 | 0.5% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.5% |
| Injurya physical injury | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bellatek Zirconia Abutment | Product code NHA | All MAUDE reports |
|---|---|---|---|
| Reports | 222 | 8,582 | 26,136,888 |
| Share of that pool | — | 2.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0% | 32.8% | 36.2% |
| Classified as malfunction | 100% | 67.1% | 62.3% |
| Filed by the manufacturer | 100% | 98.9% | 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 NHA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Certain Gold-Tite Hexed Screw | 1,394 | 91 | 0% |
| Certain Titanium Hexed Screw | 454 | 21 | 0% |
| Titanium Hexed Uniscrew | 354 | 16 | 0% |
| Gold-Tite Square Uniscrew | 214 | 7 | 0% |
| S Atlantis Abutment Ti | 213 | 164 | 0% |
| Certain Gold-Tite Tm Hexed Screw | 186 | 11 | 0% |
| Unknown ATIS abutment | 388 | 142 | 0% |
| Unknown Ankylos CX abutment | 272 | 139 | 0% |
| Unknown Ankylos abutment | 601 | 224 | 0% |
| K3pro Dental Implants | 234 | 234 | 0% |
| Certain Titanium Large Hexed Screw | 269 | 17 | 0% |
| Locator Overdenture Implant System Lodi | 3,830 | 0 | 0% |
| Z5 | 3,005 | 364 | 0% |
| Unk Mis | 1,554 | 800 | 0% |
| BioHorizons Inc. | 57,020 | 25,536 | 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 Bellatek Zirconia Abutment reports
How many FDA reports name Bellatek Zirconia Abutment?
222 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 (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (90.5%), nonstandard device (10.4%), difficult to insert (7.7%), break (6.8%) and material fragmentation (2.7%). 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 Bellatek Zirconia Abutment 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.