Straumann BLX Implant System SLActive Roxolid BL (REF 061.6308)Recalls & reported problems
Institut Straumann AG · Bone Level X Implant, Ø 4.5mm RB, SLActive® 8mm, 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 to support a replacement tooth. Most reports describe the implant failing to take hold in the bone, with some also mentioning scar tissue around it. There are 3,447 reports, including 3,447 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
- 3,490
- Deaths reported
- 0
- Injuries reported
- 3,490
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,490 adverse event reports that list this exact device (DI 07630031736567), received between Sep 28, 2018 and Sep 28, 2026 — classified as 3,490 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,367 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 Osseointegrate2,367
- Loss of Osseointegration674
- Adverse Event Without Identified Device or Use Problem392
- Difficult to Insert38
- Fracture20
- Separation Failure6
Patient problems
- No Clinical Signs, Symptoms or Conditions1,650
- Fibrosis1,234
- Pain651
- Unspecified Infection448
- Inflammation179
- Hemorrhage/Blood Loss/Bleeding143
- Swelling/ Edema131
- Tissue Damage102
Recent adverse event reports
The 25 most recent of 3,490 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 50922001 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921824 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50921692 ↗InjurySep 28, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921146 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921111 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fistula; Inflammation; Unspecified Infection
MAUDE report 50921104 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920567 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula
MAUDE report 50920550 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation; Pain
MAUDE report 50920149 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50919368 ↗InjurySep 28, 2026Difficult to Insert
The clinician reports that the day the implant was placed in ADA 3, failure occurred upon insertion. Details of surgery: Primary stability not achieved and Ridge augmentation. 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 50918734 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fistula; Inflammation; Unspecified Infection
MAUDE report 50918704 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825103 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825067 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825059 ↗InjurySep 18, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in the patient's mouth. On (b)(6) 2025, loss of osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50824748 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50807817 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50807401 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50807396 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 15, 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 50807083 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50807020 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 15, 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 50806343 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Swelling/ Edema
MAUDE report 50760980 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Swelling/ Edema
MAUDE report 50760976 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760939 ↗
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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