Straumann® BLC and TLC Implants SLActive Roxolid BL (REF 035.9710S)Recalls & reported problems
Institut Straumann AG · BLC Implant, Ø 5.5mm WB, SLActive® 10mm, 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 dental implant is placed in the jawbone. Most of its 1,071 reports describe the implant failing to bond with the bone, sometimes during insertion, and some mention pain or infection. The reports include no deaths. Reports rose to 610 in the last 12 months from 406 in the previous 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
- 1,102
- Deaths reported
- 0
- Injuries reported
- 1,102
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,102 adverse event reports that list this exact device (DI 07630031764560), received between Apr 19, 2024 and Sep 28, 2026 — classified as 1,102 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (664 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 Osseointegrate664
- Adverse Event Without Identified Device or Use Problem273
- Loss of Osseointegration113
- Difficult to Insert52
- Fracture2
- Separation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions574
- Fibrosis388
- Pain198
- Unspecified Infection103
- Inflammation54
- Hemorrhage/Blood Loss/Bleeding38
- Swelling/ Edema35
- Fistula26
Recent adverse event reports
The 25 most recent of 1,102 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 50920450 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50920153 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50920134 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919908 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919349 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918681 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50918580 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 30. On (b)(6) 2026, non-osseointegration was verified. 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 50918570 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in ADA 14. 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. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918450 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918317 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 50824714 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 50823901 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50807710 ↗InjurySep 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in ADA 18. Details of surgery: Primary stability not achieved. On (b)(6) 2026, loss of 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 50806489 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50761038 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 30, 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 50760568 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760497 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Abscess; Fistula; Swelling/ Edema; Unspecified Infection
MAUDE report 50760495 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50760476 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50760471 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50760470 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758322 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 30. 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 50758033 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 30, 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 50757896 ↗InjurySep 14, 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, Implant surface not completely covered with bone and Immediate extraction site. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Swelling, Abscess and Fistula. No further patient complications were reported.
Patient problems: Abscess; Fistula; Swelling/ Edema; Unspecified Infection
MAUDE report 50757864 ↗
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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