Straumann BLX Implant System SLActive Roxolid BL (REF 061.6312)Recalls & reported problems
Institut Straumann AG · Bone Level X Implant, Ø 4.5mm RB, SLActive® 12mm, Roxolid® · Class 2 · Implant
All models of Straumann BLX Implant System (60)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann BLX dental implant is placed in the jawbone to support a replacement tooth. Most reports describe the implant failing to bond with the bone, sometimes followed by pain, scar tissue or infection. There are 3,605 reports, including 3,605 injuries and no deaths. 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
- 3,637
- Deaths reported
- 0
- Injuries reported
- 3,637
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,637 adverse event reports that list this exact device (DI 07630031736581), received between Oct 15, 2018 and Sep 28, 2026 — classified as 3,637 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,310 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 Osseointegrate2,310
- Loss of Osseointegration669
- Adverse Event Without Identified Device or Use Problem584
- Difficult to Insert62
- Fracture14
- Separation Failure6
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1,620
- Fibrosis1,229
- Pain810
- Unspecified Infection497
- Inflammation249
- Tissue Damage172
- Swelling/ Edema170
- Hemorrhage/Blood Loss/Bleeding166
Recent adverse event reports
The 25 most recent of 3,637 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921879 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921627 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921472 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920462 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920368 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920349 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain; Swelling/ Edema
MAUDE report 50919872 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50919792 ↗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. 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 50918888 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918686 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918661 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918642 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain; Swelling/ Edema
MAUDE report 50918440 ↗InjurySep 28, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2020 in ADA 22. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50918331 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50824963 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50823985 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain
MAUDE report 50807610 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain
MAUDE report 50807605 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807472 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in FDI 25, failure occurred upon insertion. 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 50806837 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in FDI 25, failure occurred upon insertion. 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 50806835 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50806814 ↗InjurySep 17, 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 and Ridge augmentation. On (b)(6) 2026, non-osseointegration was verified. Patient presented with fair oral hygiene and inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Pain and Inflammation. No further patient complications were reported.
Patient problems: Inflammation; Pain
MAUDE report 50806458 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 3. Details of surgery: Implant surface not completely covered with bone and Ridge augmentation. On (b)(6) 2026, non-osseointegration was verified. Patient presented with fair oral hygiene and inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Pain and Inflammation. No further patient complications were reported.
Patient problems: Inflammation; Pain
MAUDE report 50806423 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Swelling/ Edema
MAUDE report 50761008 ↗
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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