Straumann BLX Ø3.5 mm ImplantsRecalls & reported problems across all models
Institut Straumann AG · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14,738
- Deaths reported
- 0
- Injuries reported
- 14,738
- Recalls
- 0
We found 12 models of Straumann BLX Ø3.5 mm Implants by Institut Straumann AG in the FDA's device registry (GUDID). Together they are named in 14,738 adverse event reports in the FDA's MAUDE database, received between Jan 28, 2020 and Sep 28, 2026 — classified as 14,738 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (10,934 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Straumann BLX Ø3.5 mm Implants problems
Device problems
- Failure to Osseointegrate10,934
- Loss of Osseointegration2,276
- Adverse Event Without Identified Device or Use Problem1,328
- Difficult to Insert165
- Fracture39
- Separation Failure19
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions7,685
- Fibrosis4,918
- Pain2,735
- Unspecified Infection1,929
- Inflammation999
- Hemorrhage/Blood Loss/Bleeding709
- Swelling/ Edema705
- Hyperresponsive to stimuli413
Straumann BLX Ø3.5 mm Implants models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Straumann BLX Ø3.5 mm Implants SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM4,257 reports
- Straumann BLX Ø3.5 mm Implants SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM3,338 reports
- Straumann BLX Ø3.5 mm Implants SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,732 reports
- Straumann BLX Ø3.5 mm Implants SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,692 reports
- Straumann BLX Ø3.5 mm Implants SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,532 reports
- Straumann BLX Ø3.5 mm Implants SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM821 reports
- Straumann BLX Ø3.5 mm Implants SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM761 reports
- Straumann BLX Ø3.5 mm Implants SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM331 reports
- Straumann BLX Ø3.5 mm Implants SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM157 reports
- Straumann BLX Ø3.5 mm Implants SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM58 reports
- Straumann BLX Ø3.5 mm Implants SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM48 reports
- Straumann BLX Ø3.5 mm Implants SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM11 reports
Recent Straumann BLX Ø3.5 mm Implants adverse event reports
The 15 most recent reports across all models, 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 50921841 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fistula; Inflammation
MAUDE report 50921740 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50921691 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50921690 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921680 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fistula; Pain; Swelling/ Edema
MAUDE report 50921634 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. On (b)(6) 2026, non-osseointegration was verified. No product was returned to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921599 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50921561 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921450 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation
MAUDE report 50920704 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50920686 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920662 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 50920547 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920489 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920382 ↗
Other Institut Straumann AG products
- Straumann Dental Implant System Roxolid SLA Impl.80 models · 377,342 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT39 models · 308,650 reports · 1 recall
- STRAUMANN DENTAL IMPLANT SYSTEM128 models · 98,339 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM42 models · 80,770 reports
- Straumann BLX Implant System60 models · 78,869 reports
- BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM14 models · 39,692 reports
- Straumann BLC and TLC Implants153 models · 20,568 reports
- ITI DENTAL IMPLANT SYSTEM60 models · 19,402 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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