Straumann® BLC and TLC Implants SLActive Roxolid BL (REF 035.9012S)Recalls & reported problems
Institut Straumann AG · BLC Implant, Ø 3.3mm RB, SLActive® 12mm, 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 implant is the subject of 1,055 adverse event reports, which mention no deaths and 1,055 injuries. Most reports describe implants that did not bond with the jawbone or lost that bond, and some mention pain, inflammation or infection. Reports rose from 380 in the previous 12 months to 626 in the latest 12 months. 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
- 1,070
- Deaths reported
- 0
- Injuries reported
- 1,070
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,070 adverse event reports that list this exact device (DI 07630031764164), received between May 13, 2024 and Sep 28, 2026 — classified as 1,070 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (812 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 Osseointegrate812
- Adverse Event Without Identified Device or Use Problem156
- Loss of Osseointegration75
- Difficult to Insert20
- Separation Failure7
Patient problems
- No Clinical Signs, Symptoms or Conditions559
- Fibrosis372
- Pain178
- Unspecified Infection142
- Inflammation88
- Swelling/ Edema59
- Hemorrhage/Blood Loss/Bleeding44
- Abscess31
Recent adverse event reports
The 25 most recent of 1,070 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919857 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918395 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826510 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826505 ↗InjurySep 18, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in FDI 43. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis and Fistula. No further patient complications were reported.
Patient problems: Fistula; Unspecified Infection
MAUDE report 50825200 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fistula; Unspecified Infection
MAUDE report 50825029 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824450 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824444 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Hyperresponsive to stimuli; Unspecified Infection
MAUDE report 50760897 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50759453 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738529 ↗InjurySep 11, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 7. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain and Inflammation. No further patient complications were reported.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 50737705 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720251 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50719689 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719082 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50718975 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50718971 ↗InjurySep 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in ADA 8. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Pain and Bleeding. No further patient complications were reported.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50718968 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50718964 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50718925 ↗InjurySep 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in ADA 26. On 2026 (b)(6), non-osseointegration was verified. Patient presented with inadequate bone quality/quantity. No product was returned to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50718809 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 50654386 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation
MAUDE report 50653995 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653527 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation
MAUDE report 50653048 ↗
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.
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