Straumann® BLC and TLC Implants SLActive Roxolid BL (REF 035.9808S)Recalls & reported problems
Institut Straumann AG · BLC Implant, Ø 6.5mm WB, SLActive® 8mm, Roxolid® · Class 2 · Implant
All models of Straumann BLC and TLC Implants (153)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann BLC dental implant has 224 adverse event reports, all describing injuries, and no deaths. Most reports describe the implant failing to bond with the jawbone, with many noting inadequate bone quality at insertion, and some describe pain or limited mobility. Reports rose from 78 in the prior year to 129 in the latest year. 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
- 236
- Deaths reported
- 0
- Injuries reported
- 236
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 236 adverse event reports that list this exact device (DI 07630031764676), received between Jul 5, 2024 and Sep 28, 2026 — classified as 236 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (135 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate135
- Adverse Event Without Identified Device or Use Problem74
- Loss of Osseointegration14
- Difficult to Insert11
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions152
- Fibrosis67
- Pain34
- Unspecified Infection17
- Inflammation10
- Swelling/ Edema6
- Fistula2
- Hemorrhage/Blood Loss/Bleeding2
Recent adverse event reports
The 25 most recent of 236 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921114 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 3, failure occurred upon insertion. Details of surgery: Primary stability not achieved and Immediate extraction site. 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 50920089 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920085 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50919926 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919892 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918713 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918528 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918526 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50918457 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918417 ↗InjurySep 17, 2026Fracture
Patient problems: Fibrosis
MAUDE report 50807787 ↗InjurySep 17, 2026Fracture
The clinician reports the implant was inserted (b)(6) 2026 in ADA 13. Details of surgery: Ridge augmentation. On (b)(6) 2026, fracture of the implant was verified. Patient presented with bone type III. 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 50806531 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760569 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759726 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 3, failure occurred upon insertion. Details of surgery: Immediate extraction site. 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 50757893 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757720 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719664 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 19, 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 50718783 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in FDI 26. On (b)(6) 2026, 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 Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain
MAUDE report 50283708 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 18, failure occurred upon insertion. Patient presented with inadequate bone quality/quantity. 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 50282861 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 18, failure occurred upon insertion. Patient presented with inadequate bone quality/quantity. 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 50281134 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in ADA 18. 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 50259148 ↗InjuryAug 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50258272 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted on (b)(6)2026 in ADA 14. On (b)(6)2026, 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 50199860 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 26. 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 50198277 ↗
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 16, 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