TrefoilRecalls & reported problems across all models
Nobel Biocare AB · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 151
- Deaths reported
- 0
- Injuries reported
- 148
- Recalls
- 0
We found 6 models of Trefoil by Nobel Biocare AB in the FDA's device registry (GUDID). Together they are named in 151 adverse event reports in the FDA's MAUDE database, received between Sep 15, 2019 and Dec 17, 2025 — classified as 148 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (88 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Trefoil problems
Device problems
- Failure to Osseointegrate88
- Loss of Osseointegration41
- Patient Device Interaction Problem10
- Adverse Event Without Identified Device or Use Problem6
- Osseointegration Problem4
- Malposition of Device2
Patient problems
- Failure of Implant119
- Pain32
- Unspecified Infection27
- No Clinical Signs, Symptoms or Conditions26
- Numbness11
Trefoil models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Trefoil™ 38320Implant, Endosseous, Root-Form71 reports
- Trefoil™ 38320IMPLANT, ENDOSSEOUS, ROOT-FORM40 reports
- Trefoil™ 38321IMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- Trefoil™ 38321IMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
- Trefoil™ 38318IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Trefoil™ 38319IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
Recent Trefoil adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833790 ↗InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833762 ↗InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833733 ↗InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833708 ↗InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833704 ↗InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833686 ↗InjuryDec 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22603586 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22603554 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22602760 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22602745 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22601729 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22601712 ↗InjuryJul 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22406530 ↗
Other Nobel Biocare AB products
- NobelActive56 models · 152,066 reports
- NobelReplace120 models · 138,221 reports · 15 recalls
- NobelParallel54 models · 132,525 reports
- NobelActive TiUltra28 models · 82,969 reports
- NobelParallel Conical Connection TiUltra27 models · 68,868 reports
- Replace Select107 models · 33,616 reports
- NobelReplace Conical Connection TiUltra15 models · 31,165 reports
- NobelSpeedy88 models · 24,246 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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