MODIFICATION TO ITI DENTAL IMPLANT SYSTEMRecalls & reported problems across all models
Institut Straumann AG · 42 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 80,770
- Deaths reported
- 0
- Injuries reported
- 80,770
- Recalls
- 0
We found 42 models of MODIFICATION TO ITI DENTAL IMPLANT SYSTEM by Institut Straumann AG in the FDA's device registry (GUDID). Together they are named in 80,770 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2019 and Sep 30, 2026 — classified as 80,770 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (49,554 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 MODIFICATION TO ITI DENTAL IMPLANT SYSTEM problems
Device problems
- Failure to Osseointegrate49,554
- Loss of Osseointegration28,900
- Fracture1,824
- Adverse Event Without Identified Device or Use Problem898
- Difficult to Insert137
- Unintended Movement81
- Unstable61
- Separation Failure28
Patient problems
- No Clinical Signs, Symptoms or Conditions42,970
- Fibrosis18,553
- Pain12,189
- Unspecified Infection10,996
- Tissue Damage9,315
- Inflammation4,506
- Hemorrhage/Blood Loss/Bleeding4,146
- Swelling/ Edema2,364
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM models
42 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM11,224 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM9,438 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM6,881 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM4,811 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM4,377 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM3,883 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM3,840 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM3,572 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM3,185 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM2,944 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM2,871 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM2,698 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM2,573 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM2,284 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM1,964 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM1,851 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM1,440 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM1,264 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM1,012 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM831 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM741 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM676 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM647 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM638 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM575 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM570 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM568 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM543 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM539 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM448 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM316 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM263 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM231 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM219 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM181 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM162 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM141 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM118 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM86 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM74 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM57 reports
- MODIFICATION TO ITI DENTAL IMPLANT SYSTEM SLA Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM34 reports
Recent MODIFICATION TO ITI DENTAL 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 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025(b)(6) in FDI 17. On 2026(b)(6), non-osseointegration was verified. Patient presented with fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Mobility and Bleeding. No further patient complications were reported.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Unspecified Infection
MAUDE report 50950227 ↗InjurySep 30, 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 50950202 ↗InjurySep 30, 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. Patient presented with bone type III and inadequate bone quality/quantity. 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 50950184 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50922026 ↗InjurySep 28, 2026Fracture
The clinician reports the implant was inserted (b)(6) 2021 in the patient's mouth. On (b)(6) 2026, fracture of the implant was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922018 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922016 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921733 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921732 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921674 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921651 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921643 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50921572 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921406 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921401 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921387 ↗
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
- 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
- Small Diameter Implant System5 models · 16,170 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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