BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM SLActive Roxolid BL (REF 021.4308G)Recalls & reported problems
Institut Straumann AG · Bone Level Implant, D 4.1mm RC SLActive® 8mm, Roxolid®, guided · Class 2 · Implant
All models of BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Straumann bone-level dental implant, a small screw-shaped implant used to anchor a tooth replacement in the jaw. Most of the 53 reports describe the implant failing to fuse with the surrounding bone, so it stays loose or has to be removed, sometimes with pain, swelling, bleeding, tissue damage or infection. All 53 involve injuries and no deaths are reported, and 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
- 53
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 07630031706843), received between Sep 12, 2019 and Apr 8, 2026 — classified as 53 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (33 reports).
1 other recall cover devices cleared under the same FDA submission (K121131); they may or may not involve this specific model.
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
- Failure to Osseointegrate33
- Loss of Osseointegration14
- Adverse Event Without Identified Device or Use Problem4
- Difficult to Remove1
- Fracture1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Tissue Damage12
- Unspecified Infection12
- Fibrosis10
- Pain10
- Hemorrhage/Blood Loss/Bleeding3
- Inflammation3
- Swelling/ Edema3
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2025 IN FDI 46. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24819110 ↗InjuryDec 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 36. ON (B)(6) 2025, NON-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 23867643 ↗InjuryJul 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2025 IN FDI 34. ON (B)(6) 2025 NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Swelling/ Edema
MAUDE report 22418956 ↗InjuryJan 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 36. ON (B)(6) 2024, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 21084062 ↗InjuryJul 26, 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 THE PATIENT'S MOUTH, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. 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 19842638 ↗InjuryJul 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN THE PATIENT'S MOUTH. ON (B)(6) 2024 NON-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 19693557 ↗InjuryJun 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 46. ON (B)(6) 2024, 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 19607848 ↗InjuryApr 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN THE PATIENT'S MOUTH. ON (B)(6) 2017, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fistula
MAUDE report 19207665 ↗InjuryDec 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN FDI 33. ON (B)(6) 2023, 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 18412409 ↗InjurySep 25, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 29. ON (B)(6) 2023, 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 17810359 ↗InjurySep 25, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 29. ON (B)(6) 2023, 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 17809508 ↗InjuryJun 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN THE PATIENT'S MOUTH. ON (B)(6) 2023, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 17155455 ↗InjuryMar 24, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2018 IN THE PATIENT'S MOUTH. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 16615251 ↗InjuryJan 16, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2013 IN THE PATIENT'S MOUTH. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, BLEEDING AND INCREASED SENSITIVITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Hyperresponsive to stimuli; Unspecified Infection
MAUDE report 16175846 ↗InjuryOct 31, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN ADA 4. ON (B)(6) 2022, 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 15701413 ↗InjuryOct 31, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN ADA 4. ON (B)(6) 2022, 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 15701002 ↗InjurySep 30, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN FDI 16. DETAILS OF SURGERY: SINUS AUGMENTATION. ON (B)(6) 2022, 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 15511328 ↗InjurySep 26, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN FDI 47. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION AND PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Unspecified Infection
MAUDE report 15488672 ↗InjurySep 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN THE PATIENT'S MOUTH. ON (B)(6) 2022, 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 15449449 ↗InjuryAug 30, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 14. ON (B)(6) 2021, 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 15322672 ↗InjuryAug 22, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN FDI 36. ON (B)(6) 2022, 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 15268599 ↗InjuryJun 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 44. ON (B)(6) 2022, 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 14625080 ↗InjuryApr 4, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 36. ON 2022-03-01, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation
MAUDE report 13998504 ↗InjuryMar 14, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 31. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND PREVIOUS BONE AUGMENTATION. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY AND INCREASED SENSITIVITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
MAUDE report 13761883 ↗InjuryMar 8, 2022Adverse 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 FDI 15, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13688041 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121131. One submission often covers many models, so check the product and lot details in each record.
- Z-0174-2015 · Sep 24, 2014 · TerminatedStraumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page