Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments SLActive Roxolid BL (REF 061.4312)Recalls & reported problems
Institut Straumann AG · BLX Ø3.75 RB, SLActive® 12mm, RXD · Class 2 · Implant
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. Its 4,349 adverse event reports mostly describe implants that did not fuse with the jawbone or later lost that bond, and some describe fibrosis, pain and infection. The reports include no deaths and 4,349 injuries. 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
- 4,376
- Deaths reported
- 0
- Injuries reported
- 4,376
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,376 adverse event reports that list this exact device (DI 07630031736512), received between Feb 19, 2019 and Sep 28, 2026 — classified as 4,376 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3,212 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 Osseointegrate3,212
- Loss of Osseointegration660
- Adverse Event Without Identified Device or Use Problem447
- Difficult to Insert42
- Fracture10
- Separation Failure10
Patient problems
- No Clinical Signs, Symptoms or Conditions2,004
- Fibrosis1,494
- Pain921
- Unspecified Infection588
- Inflammation290
- Tissue Damage252
- Hemorrhage/Blood Loss/Bleeding214
- Swelling/ Edema196
Recent adverse event reports
The 25 most recent of 4,376 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 50922004 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922002 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922000 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50921656 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50921471 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920521 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920029 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919611 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50919342 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826218 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825102 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50825084 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824734 ↗InjurySep 18, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 23. 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: Pain. No further patient complications were reported.
Patient problems: Pain
MAUDE report 50824176 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hyperresponsive to stimuli; Pain
MAUDE report 50760418 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50759549 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50759546 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759531 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759447 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50759280 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50759181 ↗InjurySep 14, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in ADA 22. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, loss of 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 50757597 ↗InjurySep 14, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in ADA 20. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, loss of 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 50757596 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 50738628 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50737929 ↗
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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