Straumann BLX Implant System SLA Roxolid BL (REF 061.6512)Recalls & reported problems
Institut Straumann AG · BLX Implant, Ø 4.5mm RB, SLA® 12mm, 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 implant is a screw-shaped device placed into bone. The 1,026 reports mostly describe the implant failing to bond with the bone, with some patients also reporting pain, infection or bleeding. The reports include 1,026 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
- 1,031
- Deaths reported
- 0
- Injuries reported
- 1,031
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,031 adverse event reports that list this exact device (DI 07630031743671), received between Sep 14, 2020 and Sep 28, 2026 — classified as 1,031 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (714 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 Osseointegrate714
- Loss of Osseointegration166
- Adverse Event Without Identified Device or Use Problem122
- Difficult to Insert23
- Fracture4
- Separation Failure4
Patient problems
- No Clinical Signs, Symptoms or Conditions523
- Fibrosis369
- Pain185
- Unspecified Infection146
- Inflammation59
- Hemorrhage/Blood Loss/Bleeding52
- Swelling/ Edema48
- Hyperresponsive to stimuli35
Recent adverse event reports
The 25 most recent of 1,031 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50920502 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920485 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50919548 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50918701 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918687 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807738 ↗InjurySep 15, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in the patient's mouth. Details of surgery: Primary stability not achieved. 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 50777333 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760918 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760917 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737960 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50737872 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720117 ↗InjurySep 10, 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. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719073 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719071 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654729 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Unspecified Infection
MAUDE report 50653944 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Unspecified Infection
MAUDE report 50652995 ↗InjuryAug 21, 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. Patient presented with 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 50377844 ↗InjuryAug 17, 2026Fracture
The clinician reports the implant was inserted (b)(6) 2022 in the patient's mouth. On (b)(6) 2026, fracture of the implant was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Infection. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50284064 ↗InjuryAug 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Hyperresponsive to stimuli; Pain
MAUDE report 50283843 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 13, failure occurred upon insertion. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. 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 50283623 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type IV. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50283345 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in ADA 28. Details of surgery: Immediate extraction site. On 2026 (b)(6), non-osseointegration was verified. Patient presented with bone type III. The device was forwarded to the manufacturer. At the event the patient experienced: Pain, Mobility, Increased Sensitivity and Fistula. No further patient complications were reported.
Patient problems: Fibrosis; Fistula; Hyperresponsive to stimuli; Pain
MAUDE report 50281357 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 13, failure occurred upon insertion. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. 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 50281238 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted on (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 50199884 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page