Straumann® BLC and TLC Implants SLActive Roxolid BL (REF 035.9010S)Recalls & reported problems
Institut Straumann AG · BLC Implant, Ø 3.3mm RB, SLActive® 10mm, 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 is placed in the jawbone. Most of its 1,185 reports describe implants that fail to fuse with the bone, and some mention pain, swelling, inflammation, infection and scar-like tissue. The reports include 1,185 injuries and no deaths. No recalls name this device. Reports rose from 379 in the previous 12 months to 769 in the last 12 months.
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
- 1,217
- Deaths reported
- 0
- Injuries reported
- 1,217
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,217 adverse event reports that list this exact device (DI 07630031764157), received between Jun 17, 2024 and Sep 28, 2026 — classified as 1,217 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (978 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 Osseointegrate978
- Loss of Osseointegration136
- Adverse Event Without Identified Device or Use Problem93
- Difficult to Insert10
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions578
- Fibrosis435
- Pain234
- Unspecified Infection206
- Inflammation112
- Swelling/ Edema73
- Fistula52
- Hemorrhage/Blood Loss/Bleeding41
Recent adverse event reports
The 25 most recent of 1,217 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 50922037 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921488 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921487 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50920534 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920306 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920265 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50919932 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919877 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50919853 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Abscess; Hemorrhage/Blood Loss/Bleeding; Inflammation; Swelling/ Edema; Unspecified Infection
MAUDE report 50919846 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50919639 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918895 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918600 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50918464 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918409 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50918374 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 21. On (b)(6) 2026, non-osseointegration was verified. Patient presented with fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Swelling, Bleeding, Abscess and Inflammation. No further patient complications were reported.
Patient problems: Abscess; Hemorrhage/Blood Loss/Bleeding; Inflammation; Swelling/ Edema; Unspecified Infection
MAUDE report 50918366 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826292 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50825061 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50824156 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in FDI 15. 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 50807809 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50758966 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758955 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hyperresponsive to stimuli; Unspecified Infection
MAUDE report 50738539 ↗InjurySep 11, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in ADA 7. Details of surgery: Implant surface not completely covered with bone. On 2026 (b)(6), non-osseointegration was verified. Patient presented with bone type III and inadequate bone quality/quantity. 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 50737516 ↗
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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