Straumann BLX Implant System SLActive Roxolid BL (REF 061.7310)Recalls & reported problems
Institut Straumann AG · BLX Implant, Ø 5.0mm WB, SLActive® 10mm, 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. Its 4,294 adverse event reports mostly describe implants that did not fuse with the jawbone or later lost that bond, and some describe fibrosis, pain and swelling. The reports include no deaths and 4,294 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
- 4,328
- Deaths reported
- 0
- Injuries reported
- 4,328
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,328 adverse event reports that list this exact device (DI 07630031743732), received between Oct 21, 2019 and Sep 28, 2026 — classified as 4,328 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,584 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 Osseointegrate2,584
- Loss of Osseointegration881
- Adverse Event Without Identified Device or Use Problem773
- Difficult to Insert75
- Fracture21
- Separation Failure12
Patient problems
- No Clinical Signs, Symptoms or Conditions2,110
- Fibrosis1,582
- Pain844
- Unspecified Infection426
- Inflammation241
- Swelling/ Edema160
- Hemorrhage/Blood Loss/Bleeding136
- Hyperresponsive to stimuli135
Recent adverse event reports
The 25 most recent of 4,328 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50921739 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation
MAUDE report 50921124 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920595 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920594 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920592 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50920562 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920394 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50920391 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50920359 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50920161 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50918649 ↗InjurySep 28, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6)2026 in ADA 5. Details of surgery: Implant surface not completely covered with bone, Ridge augmentation and Immediate extraction site. 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: Pain. No further patient complications were reported.
Patient problems: Pain
MAUDE report 50918625 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918624 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50918585 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826213 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50824922 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824863 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50824303 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807406 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2024 in FDI 36. On (b)(6) 2024, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Swelling. No further patient complications were reported.
Patient problems: Swelling/ Edema
MAUDE report 50760968 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50759791 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50759725 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50759718 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50759659 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50759100 ↗
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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