FRIADENTRecalls & reported problems across all models
Dentsply Implants Manufacturing GmbH · 23 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls
- 0
We found 23 models of FRIADENT by Dentsply Implants Manufacturing GmbH in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2023 and Sep 29, 2026 — classified as 39 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Fracture” (52 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 FRIADENT problems
Device problems
- Fracture52
- Mechanical Problem2
- Loss of Osseointegration1
- Off-Label Use1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Failure of Implant16
- Osteolysis1
- Unspecified Infection1
FRIADENT models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FRIADENT® 32464305IMPLANT, ENDOSSEOUS, ROOT-FORM25 reports
- FRIADENT® 32454305IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- FRIADENT® 32453131IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- FRIADENT® 45-5734Accessories, implant, dental, endosseous2 reports
- FRIADENT® 32462131IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- FRIADENT® 32462141IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- FRIADENT® 32462142IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- FRIADENT® 32464304IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- FRIADENT® 32451140IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32453203IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32462122IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32462125IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32462133IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32462233IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32462242IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32462253IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32462781IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32462782IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32462831IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32462833IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32462841IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32462842IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- FRIADENT® 32462851IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent FRIADENT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933789 ↗MalfunctionSep 17, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809582 ↗InjuryAug 18, 2026Fracture
It was reported that a patient experienced a fracture of a dental abutment screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50305042 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced a fracture of a dental abutment screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059390 ↗InjuryMay 28, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25317541 ↗InjuryMay 15, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185928 ↗InjuryMay 12, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153938 ↗InjuryMay 1, 2026Fracture
CUSTOMER REPORTED A FRACTURE OF SCREW - RESCUE SERVICE (B)(4). (B)(6) 2026 DIANZ470: RESCUE SERVICE WILL BE FOLLOWED UP BY CUSTOMER SERVICE AT CCO. IN CASE OF NO FURTHER CONTACT, IT IS UNDERSTOOD THAT THE DENTIST SUCCESSFULLY REMOVED THE FRAGMENT (IF ANY), AND THE IMPLANT WAS RESTORED. OTHERWISE, THE LIFETIME WARRANTY WOULD BE CLAIMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057116 ↗InjuryApr 27, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24999052 ↗MalfunctionApr 21, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948222 ↗MalfunctionApr 21, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948221 ↗InjuryApr 13, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859986 ↗InjuryApr 13, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24859940 ↗InjuryApr 6, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE. THE IMPLANT IS STILL LOADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24789193 ↗InjuryMar 31, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24743942 ↗
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
- FRIALIT12 models · 35 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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