Straumann BLX Implant System SLActive Roxolid BL (REF 061.9310)Recalls & reported problems
Institut Straumann AG · Bone Level X Implant, Ø 6.5mm WB, SLActive® 10mm, Roxolid® · Class 2 · Implant
All models of Straumann BLX Implant System (60)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann BLX SLActive dental implant is placed in the jawbone. Its 2,424 reports are all injury reports, and most describe the implant not bonding with the bone or coming loose from it. They also mention pain, infection and tissue thickening around the implant, with 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
- 2,442
- Deaths reported
- 0
- Injuries reported
- 2,442
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,442 adverse event reports that list this exact device (DI 07630031736680), received between Apr 15, 2019 and Sep 28, 2026 — classified as 2,442 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,104 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate1,104
- Adverse Event Without Identified Device or Use Problem797
- Loss of Osseointegration455
- Difficult to Insert83
- Separation Failure18
- Fracture6
Patient problems
- No Clinical Signs, Symptoms or Conditions1,322
- Fibrosis693
- Pain357
- Unspecified Infection224
- Tissue Damage152
- Inflammation117
- Swelling/ Edema65
- Hyperresponsive to stimuli61
Recent adverse event reports
The 25 most recent of 2,442 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50920336 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920030 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919920 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919836 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50918628 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918458 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918353 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826660 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in the patient's mouth, 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 50824573 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in FDI 16. Details of surgery: Immediate extraction site. On 2026 (b)(6), 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 50807117 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50760598 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759193 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in ADA 29. On (B)(6) 2026, non-osseointegration was verified. No product was returned to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50757904 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738515 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738015 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Hyperresponsive to stimuli; Pain
MAUDE report 50737878 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737598 ↗InjurySep 11, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2024 (b)(6) in ADA 14. On 2026 (b)(6), loss of osseointegration was verified. Patient presented with bone type III, fair oral hygiene, bruxism and previous bone augmentation. The device was forwarded to the manufacturer. At the event the patient experienced: Pain, Mobility, Bleeding and Increased Sensitivity. No further patient complications were reported.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Hyperresponsive to stimuli; Pain
MAUDE report 50737350 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50719562 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719440 ↗InjurySep 10, 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: Primary stability not achieved and Implant surface not completely covered with bone. 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 50718682 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654857 ↗InjuryAug 24, 2026Failure to Osseointegrate
The clinician reports the implant was inserted on (b)(6) 2026 in the patient's mouth. 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 50416478 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50416461 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50416230 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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