FRIALIT® 32362445Recalls & reported problems
Dentsply Implants Manufacturing GmbH · FRIALIT® plus Implant D3.8/L15 · Class 2 · Implant
All models of FRIALIT (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI EFRI323624452), received between Apr 7, 2026 and Jun 24, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (2 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
- Loss of Osseointegration2
- Fracture1
Patient problems
- Failure of Implant3
- Implant Pain1
- Tooth Loss1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS; MOBILITY.
Patient problems: Failure of Implant
MAUDE report 25614316 ↗InjuryApr 21, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN AND UPON INSPECTION IT WAS OBSERVED THE DENTAL IMPLANT HAD A COLLAR FRACTURE. THE DENTAL IMPLANT WAS LOST.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 24948195 ↗InjuryApr 7, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Tooth Loss
MAUDE report 24802726 ↗
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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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