Straumann® BLC and TLC Implants SLActive Roxolid BL (REF 035.9206S)Recalls & reported problems
Institut Straumann AG · BLC Implant, Ø 3.75mm RB, SLActive® 6mm, 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 a root-form dental implant placed in the jawbone to hold a replacement tooth. Its 154 reports mostly describe the implant failing to fuse with the jawbone or losing that bond, and some mention pain or infection. The reports include no deaths and 154 injuries. No recalls name this device. Reports rose from 41 in the year before to 106 in the latest year.
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
- 166
- Deaths reported
- 0
- Injuries reported
- 166
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 07630031764270), received between Apr 12, 2024 and Sep 28, 2026 — classified as 166 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (134 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 Osseointegrate134
- Loss of Osseointegration19
- Adverse Event Without Identified Device or Use Problem12
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions81
- Fibrosis71
- Pain27
- Unspecified Infection16
- Inflammation8
- Abscess5
- Hemorrhage/Blood Loss/Bleeding5
- Swelling/ Edema5
Recent adverse event reports
The 25 most recent of 166 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50920157 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50919897 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919805 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50919662 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50918582 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 4, failure occurred upon insertion. Details of surgery: Primary stability not achieved and Ridge augmentation. 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 50918349 ↗InjurySep 18, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. On 2026-08-17, 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 50826357 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720390 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720389 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720346 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654548 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50415745 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50415410 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50414429 ↗InjuryAug 14, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in FDI 44. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III and 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 50259385 ↗InjuryAug 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50258905 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025(b)(6) in the patient's mouth. On 2026(b)(6), 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 50258895 ↗InjuryAug 7, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 18. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III and 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 50179505 ↗InjuryAug 3, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50121010 ↗InjuryAug 3, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 14. 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 50118448 ↗InjuryJul 31, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 47. Details of surgery: Primary stability not achieved. On (b)(6) 2026, non-osseointegration was verified. 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 50102783 ↗InjuryJul 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 35. Details of surgery: Implant surface not completely covered with bone. 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 50088941 ↗InjuryJul 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in FDI 26. 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. At the event the patient experienced: Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain
MAUDE report 50088582 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in the patient's mouth. 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 50043558 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in FDI 47. On (B)(6) 2026, non-osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis and Pain. No further patient complications were reported.
Patient problems: Pain; Unspecified Infection
MAUDE report 50041504 ↗
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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