Trefoil™ 38320 (UDI 07332747102871)Recalls & reported problems
Nobel Biocare AB · Trefoil™ Implant CC RP 5.0x11.5+4.5mm · Class 2 · Implant
Quick summary
This Trefoil dental implant from Nobel Biocare is a root-form screw implant placed into the jawbone. Most of the 71 reports describe the implant not fusing with the surrounding bone, or fusing and then loosening later, along with pain, numbness and infection. There were no deaths and 71 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 71
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 07332747102871), received between Sep 15, 2019 and Dec 17, 2025 — classified as 71 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (50 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate50
- Loss of Osseointegration15
- Patient Device Interaction Problem4
- Malposition of Device2
Patient problems
- Failure of Implant61
- Pain32
- Unspecified Infection15
- Numbness11
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 25 most recent of 71 reports, 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 ↗InjuryJul 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19734496 ↗InjuryJul 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19734419 ↗InjuryJun 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT FAILED BECAUSE PRIMARY STABILITY COULD NOT BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17193721 ↗InjuryJun 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT FAILED BECAUSE PRIMARY STABILITY COULD NOT BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17193686 ↗InjuryJun 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT FAILED BECAUSE PRIMARY STABILITY COULD NOT BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17138233 ↗InjuryJun 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT FAILED BECAUSE PRIMARY STABILITY COULD NOT BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17138209 ↗InjuryNov 22, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15849497 ↗InjuryNov 22, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15849188 ↗InjuryNov 22, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15847977 ↗InjuryNov 22, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15846266 ↗InjuryAug 12, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15221202 ↗InjuryAug 12, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15221188 ↗InjuryAug 12, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15221165 ↗InjuryAug 12, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15221139 ↗InjuryMay 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 14290721 ↗InjuryMay 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 14290720 ↗InjuryMay 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 14290692 ↗InjuryMay 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 14290661 ↗InjuryMay 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Numbness; Pain
MAUDE report 14290658 ↗
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.