Reported Reactions

Devices › Implant, endosseous, root-form

Device brand name · Hahn tapered implant

Hahn Tapered Implant 5.0 x 10 mm: medical device reports filed with FDA

260 reports name it, 2017–2026. Manufacturer given most often on reports: Prismatik Dentalcraft. Product code DZE.

260
device reports naming the brand
0% of all MAUDE reports · about 27 a year
18
reports, 12 months to August 2026
46 in the 12 months before
13.1%
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 260 reports that name the brand "Hahn Tapered Implant 5.0 x 10 mm" (hahn tapered implant), received between January 2017 and August 2026; the manufacturer given most often on reports is Prismatik Dentalcraft. Spellings of one product vary from report to report.

18 reports arrived in the 12 months to August 2026, down 61% from 46 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 (86.9%) and malfunction (13.1%); 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 (48.8%), osseointegration problem (34.6%) and loss of osseointegration (19.2%). 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

0612Sep 2021: 3Oct 2021: 1Nov 2021: 1Dec 2021: 12022Jan 2022: 1Feb 2022: 0Mar 2022: 1Apr 2022: 1May 2022: 4Jun 2022: 2Jul 2022: 2Aug 2022: 0Sep 2022: 1Oct 2022: 3Nov 2022: 4Dec 2022: 32023Jan 2023: 0Feb 2023: 1Mar 2023: 6Apr 2023: 3May 2023: 2Jun 2023: 4Jul 2023: 6Aug 2023: 2Sep 2023: 0Oct 2023: 12Nov 2023: 3Dec 2023: 32024Jan 2024: 3Feb 2024: 4Mar 2024: 2Apr 2024: 11May 2024: 8Jun 2024: 5Jul 2024: 11Aug 2024: 4Sep 2024: 4Oct 2024: 3Nov 2024: 6Dec 2024: 52025Jan 2025: 6Feb 2025: 3Mar 2025: 5Apr 2025: 3May 2025: 2Jun 2025: 2Jul 2025: 5Aug 2025: 2Sep 2025: 1Oct 2025: 2Nov 2025: 2Dec 2025: 12026Jan 2026: 2Feb 2026: 0Mar 2026: 1Apr 2026: 2May 2026: 2Jun 2026: 0Jul 2026: 3Aug 2026: 2

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

033662017: 920172018: 1120182019: 2720192020: 1720202021: 2020212022: 2220222023: 4220232024: 6620242025: 3420252026: 122026

Event type and report source

Event type, as classified on the report

Death0%0
Injury86.9%226
Malfunction13.1%34
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%260
Voluntary report0%0
User facility report0%0
Distributor report0%0
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
Failure to osseointegrate12748.8%62.8%
Osseointegration problem9034.6%7.7%
Loss of osseointegration5019.2%22.4%
Expulsion51.9%0%
Fracturea broken bone41.5%1.6%
Insufficient device problem information31.2%0.2%
Patient device interaction problem20.8%0.3%
Defective devicethe device was defective10.4%0%
Fitting problem10.4%0%
Material split, cut or torn10.4%0%
Mechanical problema mechanical problem10.4%0.1%
Migrationthe device moved from where it was placed10.4%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)ReportsShare
Failure of implant23389.6%
Painpain, site not specified4718.1%
Inflammationinflammation4216.2%
Osteolysis197.3%
Fibrosis124.6%
Discomfortdiscomfort51.9%
Implant pain41.5%
Swelling/ edema41.5%
Bruxism31.2%
Wound dehiscencea wound reopened31.2%
Purulent discharge20.8%
Appropriate clinical signs, symptoms and conditions term/code not available10.4%
Extravasation10.4%
High blood pressure/ hypertension10.4%
Numbnessnumbness10.4%

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

In context

MeasureHahn Tapered Implant 5.0 x 10 mmProduct code DZEAll MAUDE reports
Reports2603,924,24126,136,888
Share of that pool—0%0%
Classified as death, per 1,000 reports009
Classified as injury86.9%99.2%36.2%
Classified as malfunction13.1%0.8%62.3%
Filed by the manufacturer100%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 Hahn Tapered Implant 5.0 x 10 mm reports

How many FDA reports name Hahn Tapered Implant 5.0 x 10 mm?

260 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 18 in the latest 12 months.

What kinds of events are reported?

injury (86.9%) and malfunction (13.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to osseointegrate (48.8%), osseointegration problem (34.6%), loss of osseointegration (19.2%), expulsion (1.9%) and fracture (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 Hahn Tapered Implant 5.0 x 10 mm 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.