Straumann 4 mm Short ImplantsRecalls & reported problems across all models
Institut Straumann AG · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,402
- Deaths reported
- 0
- Injuries reported
- 3,402
- Recalls
- 0
We found 3 models of Straumann 4 mm Short Implants by Institut Straumann AG in the FDA's device registry (GUDID). Together they are named in 3,402 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2019 and Sep 28, 2026 — classified as 3,402 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,368 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 4 mm Short Implants problems
Device problems
- Failure to Osseointegrate2,368
- Loss of Osseointegration919
- Adverse Event Without Identified Device or Use Problem101
- Difficult to Insert14
- Separation Failure4
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions1,695
- Fibrosis1,255
- Pain691
- Unspecified Infection366
- Inflammation176
- Swelling/ Edema139
- Hemorrhage/Blood Loss/Bleeding104
- Hypersensitivity/Allergic reaction55
Straumann 4 mm Short Implants models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Straumann 4 mm Short Implants SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM2,582 reports
- Straumann 4 mm Short Implants SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM528 reports
- Straumann 4 mm Short Implants SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM292 reports
Recent Straumann 4 mm Short 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: Fibrosis
MAUDE report 50921925 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921830 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50921827 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921166 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921164 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920514 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50920510 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis; Pain
MAUDE report 50826437 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807831 ↗InjurySep 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6)2025 in the patient's mouth. On(b)(6)2026, loss of osseointegration was verified. Patient presented with bone type IV and poor oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Peri-implantitis, Pain, Swelling and Inflammation. No further patient complications were reported.
Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50807456 ↗InjurySep 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2025 in FDI 16. On (B)(6) 2026 loss of osseointegration was verified. Patient presented with bone type IV and poor oral hygiene. No product was returned to the manufacturer. At the event the patient experienced: Infection, Peri-implantitis, Pain, Mobility and Swelling. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50807038 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806992 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806991 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760937 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760645 ↗
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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