Reported Reactions

Devices › Implant, endosseous, root-form

Device brand name · Isps1050

Adin Dental Implants: medical device reports filed with FDA

700 reports name it, 2024–2026. Manufacturer given most often on reports: Adin Dental Implants. Product code DZE.

700
device reports naming the brand
0% of all MAUDE reports · about 383 a year
382
reports, 12 months to August 2026
318 in the 12 months before
0%
classified as malfunction
0.8% across the product code
0.1%
classified as death, as reported
1 reports · not verified by FDA

FDA's MAUDE database holds 700 reports that name the brand "Adin Dental Implants" (isps1050), received between September 2024 and August 2026; the manufacturer given most often on reports is Adin Dental Implants. Spellings of one product vary from report to report.

382 reports arrived in the 12 months to August 2026, up 20% from 318 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 (99.9%) and death (0.1%); 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 osseointegration problem (42.3%), patient device interaction problem (34.6%) and loss of osseointegration (22.9%). The patient problems coded most often are inadequate osseointegration, bacterial infection and pain. 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

03263Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 19Oct 2024: 18Nov 2024: 53Dec 2024: 102025Jan 2025: 19Feb 2025: 46Mar 2025: 14Apr 2025: 20May 2025: 10Jun 2025: 35Jul 2025: 42Aug 2025: 32Sep 2025: 18Oct 2025: 19Nov 2025: 52Dec 2025: 102026Jan 2026: 20Feb 2026: 45Mar 2026: 19Apr 2026: 12May 2026: 63Jun 2026: 52Jul 2026: 25Aug 2026: 47

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

01593172024: 10020242025: 31720252026: 2832026

Event type and report source

Event type, as classified on the report

Death0.1%1
Injury99.9%699
Malfunction0%0
Other0%0
Not given0%0

Who filed the report

Manufacturer report0%0
Voluntary report6.7%47
User facility report0%0
Distributor report93.3%653
Not given0%0

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)ReportsShareShare across product code
Osseointegration problem29642.3%7.7%
Patient device interaction problem24234.6%0.3%
Loss of osseointegration16022.9%22.4%
Failure to osseointegrate10.1%62.8%
Fracturea broken bone10.1%1.6%

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)ReportsShare
Inadequate osseointegration50371.9%
Bacterial infectiona bacterial infection22331.9%
Painpain, site not specified15321.9%
Granuloma273.9%
Sinus perforation91.3%
Post operative wound infection40.6%
Intraoperative pain30.4%
Failure of implant10.1%
Nerve damage10.1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureAdin Dental ImplantsProduct code DZEAll MAUDE reports
Reports7003,924,24126,136,888
Share of that pool—0%0%
Classified as death, per 1,000 reports109
Classified as injury99.9%99.2%36.2%
Classified as malfunction0%0.8%62.3%
Filed by the manufacturer0%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

BrandReportsLatest 12 monthsClassified as death
Biohorizons Dental Implant58,73200%
BioHorizons Inc.57,02025,5360%
NobelActive Internal RP 4.3x10mm49,0989,5280%
BLT ?4.1mm RC, SLA? 10mm, TiZr, Loxim45,6509,6770%
NobelParallel CC RP 4.3x10mm44,2699,3180%
BLT ?4.1mm RC, SLActive? 10mm, TiZr, NTP41,6727,5310%
Unknown Implant39,9671,4540%
NobelReplace CC RP 4.3x10mm35,9468,1660%
NobelReplace CC PMC RP 4.3x10mm34,4478,6900%
NobelActive Internal RP 4.3x11.5mm33,1175,7040%
BLT ?3.3mm NC, SLA? 10mm, TiZr, Loxim28,6485,6950%
BLT ?4.1mm RC, SLA? 10mm, Ti, Loxim26,7248,4810%
BLT ?3.3mm NC, SLActive? 10mm, TiZr, NTP26,5404,6800%
NobelActive Internal RP 4.3x13mm25,5563,7640%
BLT ?4.1mm RC, SLA? 8mm, TiZr, Loxim24,7725,9780%

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 Adin Dental Implants reports

How many FDA reports name Adin Dental Implants?

700 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 382 in the latest 12 months.

What kinds of events are reported?

injury (99.9%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

osseointegration problem (42.3%), patient device interaction problem (34.6%), loss of osseointegration (22.9%), failure to osseointegrate (0.1%) and fracture (0.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

distributor reports (93.3%) and voluntary reports (6.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Adin Dental Implants 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.