Straumann BLX Implant System SLA Roxolid BL (REF 061.5506)Recalls & reported problems
Institut Straumann AG · BLX Implant, Ø 4.0mm RB, SLA 6mm, 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 hold a tooth replacement. Its 560 reports mostly describe the implant failing to bond with the jawbone, with some describing scar-like tissue around the implant, pain, infection and bleeding. The reports include 560 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
- 564
- Deaths reported
- 0
- Injuries reported
- 564
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 564 adverse event reports that list this exact device (DI 07630031743572), received between Oct 7, 2021 and Sep 28, 2026 — classified as 564 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (396 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 Osseointegrate396
- Loss of Osseointegration126
- Adverse Event Without Identified Device or Use Problem38
- Difficult to Insert4
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions272
- Fibrosis195
- Pain101
- Unspecified Infection93
- Hemorrhage/Blood Loss/Bleeding37
- Inflammation35
- Swelling/ Edema32
- Fistula24
Recent adverse event reports
The 25 most recent of 564 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921576 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain
MAUDE report 50807558 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50760457 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50760431 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720236 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719025 ↗InjurySep 3, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in FDI 46. 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 50593216 ↗InjuryAug 27, 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 50480812 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50414330 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50414327 ↗InjuryAug 13, 2026Failure to Osseointegrate
Patient problems: Abscess; Fibrosis; Inflammation; Swelling/ Edema
MAUDE report 50239731 ↗InjuryAug 13, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50239078 ↗InjuryAug 13, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in ADA 8. Details of surgery: Primary stability not achieved, Implant surface not completely covered with bone and Ridge augmentation. On (b)(6) 2025, 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 50238500 ↗InjuryAug 13, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in ADA 4. Details of surgery: Primary stability not achieved and Sinus augmentation. On (b)(6) 2025, non-osseointegration was verified. Patient presented with bone type III and fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility, Swelling, Abscess and Inflammation. No further patient complications were reported.
Patient problems: Abscess; Fibrosis; Inflammation; Swelling/ Edema
MAUDE report 50238197 ↗InjuryAug 13, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025 (b)(6) in ADA 8. Details of surgery: Primary stability not achieved, Implant surface not completely covered with bone and Ridge augmentation. On 2025 (b)(6), 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 50238001 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2024 in FDI 16. 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 50199883 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted on (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 50198350 ↗InjuryAug 7, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in FDI 22. On (b)(6) 2026, loss of 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
MAUDE report 50179433 ↗InjuryAug 3, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50120405 ↗InjuryAug 3, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50119515 ↗InjuryJul 31, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 14. 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: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50103319 ↗InjuryJul 31, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in ADA 14. 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: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50102377 ↗InjuryJul 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in FDI 36. On 2026(b)(6), non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain
MAUDE report 50089201 ↗InjuryJul 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2025-(b)(6) in FDI 26. On 2026-(b)(6), loss of osseointegration was verified. Patient presented with bruxism. The device was forwarded to the manufacturer. At the event the patient experienced: Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain
MAUDE report 50041332 ↗InjuryJul 13, 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. PATIENT PRESENTED WITH BONE TYPE IV. 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 25803726 ↗
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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