Trefoil™ 38321 (UDI 07332747161670)Recalls & reported problems
Nobel Biocare AB · Trefoil™ Implant CC RP 5.0x13+4.5mm · Class 2 · Implant
All models of Trefoil (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07332747161670), received between Nov 12, 2021 and Jul 4, 2025 — classified as 12 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate4
- Loss of Osseointegration4
- Patient Device Interaction Problem4
Patient problems
- Failure of Implant6
- No Clinical Signs, Symptoms or Conditions6
- Unspecified Infection2
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryJul 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22406530 ↗InjuryJul 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22406528 ↗InjuryJul 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22406527 ↗InjuryJul 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22406526 ↗InjuryJul 19, 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 17354501 ↗InjuryJul 19, 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 17354494 ↗InjuryJul 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT FAILED DUE TO LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17354449 ↗InjuryJul 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT FAILED DUE TO LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17354431 ↗InjuryFeb 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16389157 ↗InjuryFeb 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16389128 ↗InjuryNov 12, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12805952 ↗InjuryNov 12, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12805891 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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