ITI DENTAL IMPLANT SYSTEM SLA Titanium TL (REF 042.932S)Recalls & reported problems
Institut Straumann AG · Standard Plus Implant, D 3.3mm, NN, SLA 12mm, Ti · Class 2 · Implant
All models of ITI DENTAL IMPLANT SYSTEM (60)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ITI Dental Implant SLA Titanium is a dental implant placed into the jawbone. Most of the 180 reports describe the implant losing or failing to bond with the bone, and the reports include 180 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 182
- Deaths reported
- 0
- Injuries reported
- 182
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 07630031718297), received between Sep 12, 2019 and Sep 28, 2026 — classified as 182 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (125 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration125
- Failure to Osseointegrate45
- Fracture9
- Adverse Event Without Identified Device or Use Problem6
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- Unspecified Infection44
- Pain38
- Inflammation34
- Fibrosis33
- Hemorrhage/Blood Loss/Bleeding30
- Tissue Damage26
- Swelling/ Edema13
Recent adverse event reports
The 25 most recent of 182 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50921890 ↗InjurySep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921409 ↗InjuryJul 27, 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. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50042929 ↗InjuryApr 14, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2005 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: PERI-IMPLANTITIS, PAIN, SWELLING AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 24875903 ↗InjuryApr 14, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2005 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: PERI-IMPLANTITIS, PAIN, SWELLING AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 24875901 ↗InjuryJan 5, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2004 IN FDI 22. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation
MAUDE report 23965089 ↗InjuryDec 12, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2015 IN FDI 11. 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 23793208 ↗InjuryNov 21, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN THE PATIENT'S MOUTH. ON (B)(6) 2025 , LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, MOBILITY, SWELLING, BLEEDING, HYPERSENSITIVITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Pain; Swelling/ Edema
MAUDE report 23620851 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2006 IN FDI 31. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, MOBILITY AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 22753176 ↗InjuryJun 18, 2025Fracture; Fracture
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2002 IN THE PATIENT'S MOUTH. ON (B)(6) 2024, 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 22268766 ↗InjuryJun 17, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2010 IN FDI 13. ON (B)(6), LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain
MAUDE report 22230892 ↗InjuryJun 17, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2005 IN FDI 11. ON (B)(6) 2024, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 22226454 ↗InjuryJun 17, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2005 IN FDI 21. ON (B)(6) 2024, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 22226449 ↗InjuryJan 6, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2010 IN FDI 41. ON (B)(6) 2024 , 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 21084087 ↗InjuryDec 12, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2015 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: RIDGE AUGMENTATION. ON (B)(6) 2021, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Swelling/ Edema
MAUDE report 20916708 ↗InjuryNov 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN THE PATIENT'S MOUTH. ON (B)(6) 2024, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20659109 ↗InjuryNov 11, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2008 IN FDI 32. DETAILS OF SURGERY: SINUS AUGMENTATION. ON (B)(6) 2024, LOSS OF OSSEOINTEGRATION WAS VERIFIED. 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 20655210 ↗InjuryNov 8, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: RIDGE AUGMENTATION. ON (B)(6) 2022, LOSS OF 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: INFECTION, SWELLING AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection
MAUDE report 20643761 ↗InjuryNov 7, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2004 IN THE PATIENT'S MOUTH. ON 2024-08-22, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 20633158 ↗InjuryOct 21, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2020 IN THE PATIENT'S MOUTH. ON (B)(6) 2024, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Unspecified Infection
MAUDE report 20498453 ↗InjuryAug 26, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2013 IN FDI 41. ON (B)(6) 2024, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 20067384 ↗InjuryAug 12, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2004 IN FDI 14. ON (B)(6) 2024, 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 19965086 ↗InjuryAug 9, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2009 IN THE PATIENT'S MOUTH. ON (B)(6) 2024, 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 19953415 ↗InjuryJul 26, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2009 IN FDI 12. ON (B)(6) 2024, 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 19842624 ↗InjuryApr 15, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2007 IN ADA 24. ON 2024-02-21, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. 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 19107816 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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