STRAUMANN DENTAL IMPLANT SYSTEM SLActive Titanium TL (REF 033.714S)Recalls & reported problems
Institut Straumann AG · Tapered Effect Implant D 4.8mm WN, SLActive® 14mm, Ti · Class 2 · Implant
All models of STRAUMANN DENTAL IMPLANT SYSTEM (128)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07630031716422), received between Sep 16, 2019 and Jun 17, 2025 — classified as 16 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (13 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration13
- Failure to Osseointegrate3
Patient problems
- Fibrosis8
- Pain5
- Unspecified Infection5
- Swelling/ Edema3
- Swelling2
- Tissue Damage2
- Fistula1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2007 IN FDI 23. 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 22244020 ↗InjuryJan 5, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2009 IN FDI 16. DETAILS OF SURGERY: SINUS AUGMENTATION. ON (B)(6) 2023, 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 18460033 ↗InjuryFeb 21, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2010 IN FDI 16. DETAILS OF SURGERY: SINUS AUGMENTATION. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PERI-IMPLANTITIS, PAIN, MOBILITY, SWELLING, BLEEDING, FISTULA AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Fistula; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 16412028 ↗InjuryJan 11, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV. 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 16139309 ↗InjuryOct 17, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2013 IN FDI 27. DETAILS OF SURGERY: RIDGE AUGMENTATION. ON (B)(6) 2022, 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 15619154 ↗InjuryApr 11, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN FDI 37. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2022, 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 14075977 ↗InjuryApr 4, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2008 IN ADA 19. DETAILS OF SURGERY: RIDGE AUGMENTATION. ON (B)(6) 2022, 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 13997578 ↗InjuryApr 4, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2008 IN ADA 19. DETAILS OF SURGERY: RIDGE AUGMENTATION. ON (B)(6) 2022, 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 13996807 ↗InjuryMar 15, 2021Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2010 IN ADA 14. ON (B)(6) 2020, LOSS OF 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 11487627 ↗InjuryMar 15, 2021Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2010 IN ADA 14. ON (B)(6) 2020, LOSS OF 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 11486812 ↗InjuryNov 27, 2020Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 2. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 10914247 ↗InjuryNov 27, 2020Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 2. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 10914049 ↗InjuryFeb 17, 2020Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN FDI 46. ON (B)(6) 2020, 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: Pain; Tissue Damage
MAUDE report 9718354 ↗InjuryDec 6, 2019Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2012 IN ADA 30. DETAILS OF SURGERY: RIDGE AUGMENTATION AND IMMEDIATE EXTRACTION SITE. ON (B)(6) 2019, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Swelling; Unspecified Infection
MAUDE report 9424713 ↗InjuryDec 6, 2019Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2012 IN ADA 30. DETAILS OF SURGERY: RIDGE AUGMENTATION AND IMMEDIATE EXTRACTION SITE. ON (B)(6) 2019 LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Swelling; Unspecified Infection
MAUDE report 9422878 ↗InjurySep 16, 2019Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2015 IN FDI 26 OF THE PATIENT'S MOUTH. ON (B)(6) 2018, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: Tissue Damage
MAUDE report 9073612 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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