Straumann BLX Ø3.5 mm Implants SLActive Roxolid BL (REF 061.3314)Recalls & reported problems
Institut Straumann AG · BLX Implant, Ø 3.5mm RB, SLActive® 14mm, Roxolid® · Class 2 · Implant
All models of Straumann BLX Ø3.5 mm Implants (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann BLX dental implant is placed in the jawbone. Its 819 reports are all injuries, with no deaths. Most describe the implant failing to bond with the bone, and some describe tissue hardening, pain or infection around it. 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
- 821
- Deaths reported
- 0
- Injuries reported
- 821
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 821 adverse event reports that list this exact device (DI 07630031743305), received between Mar 19, 2020 and Sep 28, 2026 — classified as 821 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (613 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
- Failure to Osseointegrate613
- Loss of Osseointegration94
- Adverse Event Without Identified Device or Use Problem90
- Difficult to Insert19
- Fracture7
- Separation Failure3
Patient problems
- No Clinical Signs, Symptoms or Conditions507
- Fibrosis227
- Pain139
- Unspecified Infection66
- Inflammation37
- Swelling/ Edema25
- Hemorrhage/Blood Loss/Bleeding20
- Hyperresponsive to stimuli20
Recent adverse event reports
The 25 most recent of 821 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919393 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824871 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760528 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760520 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50760405 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757882 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 22. 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 50757873 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 50738437 ↗InjuryAug 31, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2022 in the patient's mouth. On (b)(6) 2022, 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 50528086 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50415497 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50414498 ↗InjuryAug 24, 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 50414368 ↗InjuryAug 24, 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 50414366 ↗InjuryAug 24, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 11. 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 50413414 ↗InjuryAug 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. 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 50284101 ↗InjuryAug 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. 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 50284086 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in FDI 15. Details of surgery: Implant surface not completely covered with bone. 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 50282988 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 24. Details of surgery: Implant surface not completely covered with bone. 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 50282987 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2024 (b)(6) in the patient's mouth. 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 50282205 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 14. On (b)(6) 2026, non-osseointegration was verified. 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 50199126 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2023 in ADA 11. 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 50198572 ↗InjuryAug 10, 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. 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 50198502 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 7. 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 50198274 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in ADA 2. 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 50198271 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2023 in ADA 11. 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 50197116 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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