Straumann BLX Implant System SLActive Roxolid BL (REF 061.6310)Recalls & reported problems
Institut Straumann AG · Bone Level X Implant, Ø 4.5mm RB, SLActive® 10mm, Roxolid® · Class 2 · Implant
Quick summary
This Straumann BLX implant is placed in the jawbone. The reports mostly describe implants that did not bond with the bone, with some also mentioning pain or infection. FDA records list 5,446 reports, no deaths, 5,446 injuries and no malfunction reports. 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
- 5,491
- Deaths reported
- 0
- Injuries reported
- 5,491
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5,491 adverse event reports that list this exact device (DI 07630031736574), received between Dec 28, 2018 and Sep 28, 2026 — classified as 5,491 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3,657 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 Osseointegrate3,657
- Loss of Osseointegration983
- Adverse Event Without Identified Device or Use Problem742
- Difficult to Insert79
- Fracture50
- Separation Failure15
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions2,637
- Fibrosis1,796
- Pain1,067
- Unspecified Infection694
- Inflammation329
- Tissue Damage252
- Hemorrhage/Blood Loss/Bleeding209
- Swelling/ Edema201
Recent adverse event reports
The 25 most recent of 5,491 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 50921860 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50921694 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921170 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921087 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920769 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920434 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 50920122 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919879 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50919339 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918673 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 15. 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 50918441 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50826382 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50826353 ↗InjurySep 18, 2026Fracture
Patient problems: Swelling/ Edema
MAUDE report 50826272 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826251 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824864 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50824749 ↗InjurySep 18, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2024 in the patient's mouth. On (B)(6) 2025 loss of osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Infection. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50824739 ↗InjurySep 18, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2024 in the patient's mouth. On (B)(6) 2025, loss of osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Infection and Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50824738 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50824733 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807839 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50807822 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Hyperresponsive to stimuli; Pain
MAUDE report 50807697 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain
MAUDE report 50807609 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain
MAUDE report 50807607 ↗
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.