FRIALITRecalls & reported problems across all models
Dentsply Implants Manufacturing GmbH · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls
- 0
We found 12 models of FRIALIT by Dentsply Implants Manufacturing GmbH in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Jul 31, 2023 and Jun 24, 2026 — classified as 35 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (32 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 FRIALIT problems
Device problems
- Loss of Osseointegration32
- Fracture2
- Failure to Osseointegrate1
- Off-Label Use1
Patient problems
- Failure of Implant35
- Inflammation11
- Osteolysis8
- Pocket Erosion3
- Unspecified Infection3
- Implant Pain1
- Tooth Loss1
FRIALIT models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FRIALIT® 32362451IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- FRIALIT® 32362431IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- FRIALIT® 32362441IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- FRIALIT® 32362461IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- FRIALIT® 32362443IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- FRIALIT® 32362445IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- FRIALIT® 32362453IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- FRIALIT® 32362433IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- FRIALIT® 32362463IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- FRIALIT® 32362450IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIALIT® 32362455IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIALIT® 32362460IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent FRIALIT adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryMay 29, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH PERIIMPLANTITIS.
Patient problems: Failure of Implant
MAUDE report 25335127 ↗InjuryApr 22, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24960311 ↗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 8, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24819463 ↗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 ↗InjuryMar 6, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS AND PERIIMPLANTITIS.
Patient problems: Failure of Implant
MAUDE report 24536746 ↗InjuryFeb 27, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS, PERIIMPLANTITIS, AND BONE LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 24468974 ↗InjuryFeb 13, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24334932 ↗InjuryFeb 13, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24334916 ↗InjuryNov 14, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED MOBILITY ISSUES AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23552510 ↗InjuryNov 14, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED OSTEOLYSIS AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 23552508 ↗InjuryNov 6, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23493834 ↗InjuryNov 5, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 23482491 ↗InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 23280482 ↗
Other Dentsply Implants Manufacturing GmbH products
- ASTRA TECH Implant System EV177 models · 37,200 reports
- ASTRA TECH Implant System166 models · 27,749 reports
- ANKYLOS112 models · 20,917 reports
- XiVE62 models · 12,456 reports
- DS PrimeTaper61 models · 6,897 reports
- DS OmniTaper32 models · 2,128 reports
- DS Implants44 models · 145 reports
- FRIADENT23 models · 55 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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