Small Diameter Implant SystemRecalls & reported problems across all models
Institut Straumann AG · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16,170
- Deaths reported
- 0
- Injuries reported
- 16,170
- Recalls
- 0
We found 5 models of Small Diameter Implant System by Institut Straumann AG in the FDA's device registry (GUDID). Together they are named in 16,170 adverse event reports in the FDA's MAUDE database, received between Feb 5, 2018 and Sep 28, 2026 — classified as 16,170 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (12,409 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 Small Diameter Implant System problems
Device problems
- Failure to Osseointegrate12,409
- Loss of Osseointegration2,245
- Adverse Event Without Identified Device or Use Problem1,097
- Difficult to Insert233
- Fracture171
- Separation Failure65
- Difficult to Remove25
- Unstable9
Patient problems
- No Clinical Signs, Symptoms or Conditions5,842
- Fibrosis5,308
- Pain3,145
- Unspecified Infection2,572
- Tissue Damage2,112
- Inflammation1,407
- Swelling/ Edema881
- Fistula861
Small Diameter Implant System models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Small Diameter Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM6,898 reports
- Small Diameter Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM6,736 reports
- Small Diameter Implant System SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM1,600 reports
- Small Diameter Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM769 reports
- Small Diameter Implant System SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM167 reports
Recent Small Diameter Implant System 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: Fibrosis
MAUDE report 50921907 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain; Swelling/ Edema
MAUDE report 50921625 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921594 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921086 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921082 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921080 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in FDI 33. On (b)(6) 2026, non-osseointegration was verified. 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 50920627 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50920100 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919804 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919657 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50919570 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918762 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918712 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918703 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50918549 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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