PURE Ceramic ImplantsRecalls & reported problems across all models
Institut Straumann AG · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,757
- Deaths reported
- 0
- Injuries reported
- 1,757
- Recalls
- 0
We found 16 models of PURE Ceramic Implants by Institut Straumann AG in the FDA's device registry (GUDID). Together they are named in 1,757 adverse event reports in the FDA's MAUDE database, received between Feb 6, 2018 and Sep 17, 2026 — classified as 1,757 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,175 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 PURE Ceramic Implants problems
Device problems
- Failure to Osseointegrate1,175
- Loss of Osseointegration443
- Adverse Event Without Identified Device or Use Problem96
- Fracture32
- Difficult to Insert21
- Difficult to Remove2
- Separation Failure2
- Unstable1
Patient problems
- Fibrosis661
- No Clinical Signs, Symptoms or Conditions469
- Pain463
- Tissue Damage333
- Unspecified Infection222
- Inflammation175
- Hemorrhage/Blood Loss/Bleeding153
- Swelling/ Edema78
PURE Ceramic Implants models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM317 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM291 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM183 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM172 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM164 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM127 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM113 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM78 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM75 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM74 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM64 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM37 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM23 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM16 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
- PURE Ceramic Implants Ceramic TLIMPLANT, ENDOSSEOUS, ROOT-FORM11 reports
Recent PURE Ceramic Implants adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 17, 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. Patient presented with bone type III. 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 50807145 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738446 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654232 ↗InjuryAug 20, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50353333 ↗InjuryAug 20, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2017 in ADA 14. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bruxism, inadequate bone quality/quantity and previous bone augmentation. 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 50351652 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2015 in FDI 36. On (b)(6) 2026, 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 50283527 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2025 (b)(6) in FDI 16. On 2026 (b)(6), 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 50282042 ↗InjuryAug 14, 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 50259128 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025(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 50259126 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 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 50259123 ↗InjuryAug 6, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50163595 ↗InjuryJul 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2024 in FDI 24. 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 50023539 ↗InjuryJul 13, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis
MAUDE report 25801627 ↗InjuryJul 13, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. ON (B)(6) 2026, 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 25801585 ↗InjuryJul 6, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 25. 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 25723014 ↗
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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