Straumann BLX Implant System SLActive Roxolid BL (REF 061.5308)Recalls & reported problems
Institut Straumann AG · BLX Implant, Ø 4.0mm RB, SLActive® 8mm, Roxolid® · Class 2 · Implant
Quick summary
This Straumann BLX dental implant is a root-form implant placed in the jawbone. Its 3,222 reports mostly describe the implant failing to fuse with the jawbone, with patients reporting scar tissue, pain and swelling. The reports include no deaths and 3,222 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
- 3,244
- Deaths reported
- 0
- Injuries reported
- 3,244
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,244 adverse event reports that list this exact device (DI 07630031743510), received between Jul 24, 2019 and Sep 28, 2026 — classified as 3,244 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,395 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate2,395
- Loss of Osseointegration574
- Adverse Event Without Identified Device or Use Problem244
- Difficult to Insert26
- Fracture10
- Separation Failure5
Patient problems
- No Clinical Signs, Symptoms or Conditions1,517
- Fibrosis1,200
- Pain653
- Unspecified Infection414
- Inflammation202
- Swelling/ Edema141
- Hemorrhage/Blood Loss/Bleeding114
- Tissue Damage64
Recent adverse event reports
The 25 most recent of 3,244 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 50921906 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921441 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50920708 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920324 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920316 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920053 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826264 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding
MAUDE report 50824961 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding
MAUDE report 50823968 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in FDI 26. 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 50807794 ↗InjurySep 15, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in FDI 45. 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: Pain. No further patient complications were reported.
Patient problems: Pain
MAUDE report 50777368 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760987 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Swelling/ Edema
MAUDE report 50760974 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50760854 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760811 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50760508 ↗InjurySep 14, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2022 in FDI 27. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760079 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759814 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Abscess; Hemorrhage/Blood Loss/Bleeding; Inflammation; Unspecified Infection
MAUDE report 50759713 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50759616 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759446 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 13. Details of surgery: Primary stability not achieved, Implant surface not completely covered with bone and Immediate extraction site. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III. 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 50757870 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Abscess; Hemorrhage/Blood Loss/Bleeding; Inflammation; Unspecified Infection
MAUDE report 50757704 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738564 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738559 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.