Straumann® BLC and TLC Implants SLA Roxolid BL (REF 035.8408S)Recalls & reported problems
Institut Straumann AG · BLC Implant, Ø 4.5mm WB, SLA® 8mm, Roxolid® · Class 2 · Implant
All models of Straumann BLC and TLC Implants (153)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann BLC and TLC dental implant has 93 adverse event reports, all describing injuries and no deaths. Most reports describe implants failing to integrate with bone, sometimes with infection, pain or swelling. There are no recalls naming this device. Reports rose sharply from 2 in the prior 12 months to 91 in the most recent 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
- 107
- Deaths reported
- 0
- Injuries reported
- 107
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 07630031764355), received between Sep 8, 2025 and Sep 28, 2026 — classified as 107 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (84 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate84
- Adverse Event Without Identified Device or Use Problem15
- Loss of Osseointegration6
- Difficult to Insert1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- Unspecified Infection28
- Pain24
- Fibrosis21
- Swelling/ Edema8
- Hemorrhage/Blood Loss/Bleeding6
- Inflammation5
- Abscess4
Recent adverse event reports
The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50921797 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825010 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824088 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in the patient's mouth. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. 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 50759443 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758985 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758325 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 3. 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 50757549 ↗InjurySep 11, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in ADA 18. On 2026 (b)(6), non-osseointegration was verified. Patient presented with fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Pain, Mobility, Swelling, Bleeding and Abscess. No further patient complications were reported.
Patient problems: Abscess; Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50739074 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation; Unspecified Infection
MAUDE report 50737918 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50737906 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50737858 ↗InjurySep 11, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in ADA 18. On 2026 (b)(6), non-osseointegration was verified. Patient presented with fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Pain, Mobility, Swelling, Bleeding and Abscess. No further patient complications were reported.
Patient problems: Abscess; Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50737726 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719653 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 50654809 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50654621 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50415653 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50415643 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50415337 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50414586 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50414229 ↗InjuryAug 20, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type IV. No product was returned to the manufacturer. At the event the patient experienced: Inflammation. No further patient complications were reported.
Patient problems: Inflammation
MAUDE report 50351888 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in the patient's mouth. Details of surgery: Implant surface not completely covered with bone. On (b)(6)2026, non-osseointegration was verified. Patient presented with inadequate bone quality/quantity. No product was returned 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 50283492 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with inadequate bone quality/quantity. No product was returned to the manufacturer. At the event the patient experienced: Infection, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50283478 ↗InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50258944 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in ADA 13. On 2026(b)(6), non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Pain. No further patient complications were reported.
Patient problems: Pain
MAUDE report 50258841 ↗
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.
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