BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsRecalls & reported problems across all models
Institut Straumann AG · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 111
- Deaths reported
- 0
- Injuries reported
- 111
- Recalls
- 0
We found 8 models of BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants by Institut Straumann AG in the FDA's device registry (GUDID). Together they are named in 111 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2022 and Jul 13, 2026 — classified as 111 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (50 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 BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants problems
Device problems
- Failure to Osseointegrate50
- Adverse Event Without Identified Device or Use Problem41
- Loss of Osseointegration9
- Difficult to Insert7
- Fracture3
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions71
- Fibrosis24
- Pain11
- Unspecified Infection11
- Abscess4
- Inflammation3
- Hemorrhage/Blood Loss/Bleeding2
- Hyperresponsive to stimuli2
BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM41 reports
- BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM27 reports
- BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM25 reports
- BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants SLActive Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 And L16) Implants SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants SLA Roxolid BLIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
Recent BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 13, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 36. 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 25801420 ↗InjuryJul 13, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 19. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR 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 25800285 ↗InjuryJul 13, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 19. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR 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 25799183 ↗InjuryJun 15, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN THE PATIENT'S MOUTH. ON (B)(6) 2024, 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 25508955 ↗InjuryJun 8, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 25. ON (B)(6) 2026, 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 25434316 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN FDI 16, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. PATIENT PRESENTED WITH BONE TYPE III. 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 25379889 ↗InjuryJun 3, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN FDI 24. 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 25378697 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN ADA 19, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. 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 25245130 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN ADA 19, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. 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 25244801 ↗InjuryMay 18, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2024 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25207506 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN THE PATIENT'S MOUTH, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. 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 25189387 ↗InjuryMay 15, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 18. ON (B)(6) 2026, NON-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 25189225 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN THE PATIENT'S MOUTH, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. 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 25187822 ↗InjuryMay 15, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN ADA 18. ON (B)(6) 2026, NON-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 25187787 ↗InjuryMay 12, 2026Separation Failure
THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN FDI 13, FAILURE OCCURRED UPON INSERTION. 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 25151811 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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