Straumann BLX Implant System SLActive Roxolid BL (REF 061.5314)Recalls & reported problems
Institut Straumann AG · BLX Implant, Ø 4.0mm RB, SLActive® 14mm, Roxolid® · Class 2 · Implant
All models of Straumann BLX Implant System (60)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann BLX dental implant is placed in the jawbone. Many of the 1,375 reports describe the implant not bonding with the bone, along with pain, infection or bleeding around it. The reports include no deaths and 1,375 injuries. 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
- 1,397
- Deaths reported
- 0
- Injuries reported
- 1,397
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,397 adverse event reports that list this exact device (DI 07630031743541), received between Oct 28, 2019 and Sep 28, 2026 — classified as 1,397 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (942 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 Osseointegrate942
- Adverse Event Without Identified Device or Use Problem232
- Loss of Osseointegration192
- Difficult to Insert31
- Fracture4
- Separation Failure4
Patient problems
- No Clinical Signs, Symptoms or Conditions773
- Fibrosis413
- Pain261
- Unspecified Infection171
- Hemorrhage/Blood Loss/Bleeding68
- Inflammation59
- Hyperresponsive to stimuli45
- Swelling/ Edema41
Recent adverse event reports
The 25 most recent of 1,397 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 50921997 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921928 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921912 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921530 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50921480 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920275 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920272 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918607 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918603 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761015 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760527 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 50759573 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 12, failure occurred upon insertion. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. Patient presented with bone type IV 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 50758018 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757884 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 24. 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: Infection, Pain, Mobility and Inflammation. No further patient complications were reported.
Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 50757633 ↗InjurySep 11, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 16. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type IV, poor oral hygiene 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 50738342 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Pain; Swelling/ Edema
MAUDE report 50719670 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50719655 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fistula; Hemorrhage/Blood Loss/Bleeding
MAUDE report 50655397 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50655336 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50654515 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50654273 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50654272 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653223 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 22. Details of surgery: Ridge augmentation and Immediate extraction site. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Pain, Swelling and Abscess. No further patient complications were reported.
Patient problems: Abscess; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50480945 ↗
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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