Straumann Bone Level Tapered ImplantsRecalls & reported problems across all models
Institut Straumann AG · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 444
- Deaths reported
- 0
- Injuries reported
- 444
- Recalls
- 0
We found 6 models of Straumann Bone Level Tapered Implants by Institut Straumann AG in the FDA's device registry (GUDID). Together they are named in 444 adverse event reports in the FDA's MAUDE database, received between Feb 7, 2018 and Sep 28, 2026 — classified as 444 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (292 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 Bone Level Tapered Implants problems
Device problems
- Failure to Osseointegrate292
- Loss of Osseointegration121
- Adverse Event Without Identified Device or Use Problem30
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions188
- Fibrosis139
- Pain101
- Hemorrhage/Blood Loss/Bleeding67
- Unspecified Infection67
- Inflammation36
- Swelling/ Edema32
- Tissue Damage29
Straumann Bone Level Tapered Implants models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Straumann Bone Level Tapered Implants SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM156 reports
- Straumann Bone Level Tapered Implants SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM124 reports
- Straumann Bone Level Tapered Implants SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM54 reports
- Straumann Bone Level Tapered Implants SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM46 reports
- Straumann Bone Level Tapered Implants SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM36 reports
- Straumann Bone Level Tapered Implants SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM28 reports
Recent Straumann Bone Level Tapered 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; Pain
MAUDE report 50919822 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50918363 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719387 ↗InjurySep 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 42. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III and poor oral hygiene. 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 50719288 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719286 ↗InjuryAug 17, 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. 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 50283869 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2024 in ADA 14. On (b)(6) 2026, loss of osseointegration was verified. 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 50281376 ↗InjuryAug 13, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50238524 ↗InjuryAug 13, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2021 in ADA 27. On (b)(6) 2025, loss of osseointegration was verified. Patient presented with fair oral hygiene and inadequate bone quality/quantity. 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 50238055 ↗InjuryAug 10, 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. 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 50199124 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in FDI 32. Details of surgery: Implant surface not completely covered with bone and Immediate extraction site. 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 50197770 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in FDI 42. Details of surgery: Implant surface not completely covered with bone and Immediate extraction site. 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 50197767 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in the patient's mouth. On 2026 (b)(6), 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 50197337 ↗InjuryAug 3, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50120112 ↗InjuryJul 30, 2026Fracture
The clinician reports the implant was inserted (b)(6) 2023 in ADA 25. Details of surgery: Immediate extraction site. On (b)(6) 2026, fracture of the implant 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 50088202 ↗
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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