Straumann RidgeFit Implants Mini Implants (REF 042.949S)Recalls & reported problems
Institut Straumann AG · Straumann® RidgeFit Implant, Ø 2.4mm, GH 2.8mm, SLA®, 14mm, TiN, Roxolid® · Class 2 · Implant
Quick summary
This Straumann RidgeFit mini dental implant is a small root-form implant used to anchor replacement teeth in the jaw. Most of the 58 reports describe the implant failing to fuse with the surrounding bone, so it later becomes loose or falls out, sometimes with pain, swelling, infection or an abscess; no deaths were reported. Reports naming this device fell from 10 in the earlier 12 months to 4 in the latest. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 58
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 07630031753649), received between May 10, 2021 and Apr 9, 2026 — classified as 58 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (46 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate46
- Loss of Osseointegration8
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Fibrosis32
- No Clinical Signs, Symptoms or Conditions20
- Pain16
- Unspecified Infection8
- Abscess4
- Inflammation2
- Swelling/ Edema2
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 7. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. 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 24833859 ↗InjuryApr 9, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 7. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. 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 24833256 ↗InjuryNov 20, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN ADA 6. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, 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 23608371 ↗InjuryNov 20, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN ADA 6. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, 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 23607785 ↗InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN ADA 11, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 23339638 ↗InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN ADA 11, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 23338079 ↗InjuryAug 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 7. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. 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 22705701 ↗InjuryAug 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 7. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. 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 22702955 ↗InjuryJul 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, NON-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 22404880 ↗InjuryJul 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 8. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, NON-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 22404617 ↗InjuryJul 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, NON-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 22404155 ↗InjuryJul 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 8. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, NON-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 22404029 ↗InjuryJun 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN ADA 20. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED, IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE AND RIDGE AUGMENTATION. ON (B)(6) 2025, NON-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 22227731 ↗InjuryJun 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2024 IN ADA 20. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED, IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE AND RIDGE AUGMENTATION. ON (B)(6) 2025, NON-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 22223512 ↗InjurySep 20, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN ADA 7. ON (B)(6) 2024 LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, MOBILITY AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 20270174 ↗InjurySep 20, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN ADA 7. ON (B)(6) 2024 , LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, MOBILITY AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 20269480 ↗InjuryJun 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN ADA 25. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2024, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, MOBILITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Inflammation; Pain
MAUDE report 19550798 ↗InjuryJun 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN ADA 25. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2024, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, MOBILITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Inflammation; Pain
MAUDE report 19549463 ↗InjuryApr 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 23. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2024, 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 19111792 ↗InjuryApr 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 23. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2024, 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 19107116 ↗InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN ADA 11, FAILURE OCCURRED UPON INSERTION. 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 19099403 ↗InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN ADA 11, FAILURE OCCURRED UPON INSERTION. 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 19098882 ↗InjuryApr 5, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2023 IN ADA 27. ON (B)(6) 2024, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain
MAUDE report 19053024 ↗InjuryApr 5, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 27. ON (B)(6) 2024, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain
MAUDE report 19052394 ↗InjuryMar 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN ADA 5. ON (B)(6) 2024, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain
MAUDE report 18972432 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.