MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTSRecalls & reported problems across all models
Institut Straumann AG · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 236
- Deaths reported
- 0
- Injuries reported
- 236
- Recalls
- 0
We found 20 models of MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS by Institut Straumann AG in the FDA's device registry (GUDID). Together they are named in 236 adverse event reports in the FDA's MAUDE database, received between Sep 13, 2019 and Sep 10, 2026 — classified as 236 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (120 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:STRAUMANN GUIDED INSTRUMENTS problems
Device problems
- Failure to Osseointegrate120
- Loss of Osseointegration96
- Fracture12
- Adverse Event Without Identified Device or Use Problem4
- Difficult to Insert3
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions102
- Fibrosis58
- Pain53
- Tissue Damage43
- Unspecified Infection27
- Hemorrhage/Blood Loss/Bleeding19
- Inflammation12
- Failure of Implant9
MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM48 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM46 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM29 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium BLIMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM15 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium BLIMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium BLIMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium BLIMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium BLIMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium BLIMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium TLIMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Roxolid TLIMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719454 ↗InjurySep 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2019 in ADA 22. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with fair oral hygiene. 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 50718726 ↗InjuryAug 3, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50119146 ↗InjuryJul 17, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2009 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, LOSS OF 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 25859536 ↗InjuryJun 8, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN FDI 46. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION 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 25434780 ↗InjuryMay 15, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2009 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, MOBILITY, FISTULA AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Fistula; Inflammation; Pain
MAUDE report 25189716 ↗InjuryFeb 16, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION 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 24348396 ↗InjuryFeb 9, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 24. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND INADEQUATE BONE QUALITY/QUANTITY. 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 24296037 ↗InjuryFeb 2, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2010 IN FDI 35. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding
MAUDE report 24237677 ↗InjuryNov 3, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2010 IN FDI 18. ON (B)(6) 2025, LOSS OF 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 23455057 ↗InjurySep 9, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION 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 23007798 ↗InjuryAug 4, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2017 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION 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 22706247 ↗InjuryJun 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 16. ON (B)(6) 2024, NON-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 22315159 ↗InjuryJun 20, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN FDI 21. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE AND RIDGE AUGMENTATION. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 22300590 ↗InjuryJun 18, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION 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 22278336 ↗
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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