Straumann RidgeFit ImplantsRecalls & reported problems across all models
Institut Straumann AG · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 769
- Deaths reported
- 0
- Injuries reported
- 769
- Recalls
- 0
We found 7 models of Straumann RidgeFit Implants by Institut Straumann AG in the FDA's device registry (GUDID). Together they are named in 769 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2020 and Aug 24, 2026 — classified as 769 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (544 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 Straumann RidgeFit Implants problems
Device problems
- Failure to Osseointegrate544
- Loss of Osseointegration175
- Adverse Event Without Identified Device or Use Problem26
- Fracture20
- Difficult to Insert4
Patient problems
- Fibrosis400
- No Clinical Signs, Symptoms or Conditions294
- Pain227
- Unspecified Infection105
- Inflammation80
- Hyperresponsive to stimuli43
- Swelling/ Edema40
- Hemorrhage/Blood Loss/Bleeding20
Straumann RidgeFit Implants models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Straumann RidgeFit Implants Mini ImplantsIMPLANT, ENDOSSEOUS, ROOT-FORM401 reports
- Straumann RidgeFit Implants Mini ImplantsIMPLANT, ENDOSSEOUS, ROOT-FORM197 reports
- Straumann RidgeFit Implants Mini ImplantsIMPLANT, ENDOSSEOUS, ROOT-FORM58 reports
- Straumann RidgeFit Implants Mini ImplantsIMPLANT, ENDOSSEOUS, ROOT-FORM44 reports
- Straumann RidgeFit Implants Mini ImplantsIMPLANT, ENDOSSEOUS, ROOT-FORM28 reports
- Straumann RidgeFit Implants Mini ImplantsIMPLANT, ENDOSSEOUS, ROOT-FORM27 reports
- Straumann RidgeFit Implants Mini ImplantsIMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
Recent Straumann RidgeFit Implants adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50415173 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50413343 ↗InjuryJul 31, 2026Loss of Osseointegration
The clinician reports the implant was inserted on (b)(6)2023 in ADA 4. Details of surgery: Implant surface not completely covered with bone and Ridge augmentation. On (b)(6)2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50102942 ↗InjuryJul 31, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2023 in ADA 4. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50102755 ↗InjuryJul 31, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2023 in ADA 4. Details of surgery: Implant surface not completely covered with bone and Ridge augmentation. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50102243 ↗InjuryJul 31, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2023 in ADA 4. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50102113 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 27. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50043285 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026- in ADA 23. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50043279 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 22. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50043277 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 23. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50039882 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in ADA 22. On 2026 (b)(6), non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50039879 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in ADA 27. On 2026 (b)(6), non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50039867 ↗InjuryJul 17, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 4. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25858330 ↗InjuryJul 3, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2026 IN ADA 25. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25705934 ↗InjuryJul 3, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 25. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25705356 ↗
Other Institut Straumann AG products
- Straumann Dental Implant System Roxolid SLA Impl.80 models · 377,342 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT39 models · 308,650 reports · 1 recall
- STRAUMANN DENTAL IMPLANT SYSTEM128 models · 98,339 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM42 models · 80,770 reports
- Straumann BLX Implant System60 models · 78,869 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM14 models · 39,692 reports
- Straumann BLC and TLC Implants153 models · 20,568 reports
- ITI DENTAL IMPLANT SYSTEM60 models · 19,402 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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