Straumann BLX Ø3.5 mm Implants SLA Roxolid BL (REF 061.3512)Recalls & reported problems
Institut Straumann AG · BLX Implant, Ø 3.5mm RB, SLA® 12mm, 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 a root-form implant placed in the jawbone. The 1,524 reports most often describe the implant failing to bond with the surrounding bone, and patients reporting fibrosis, pain, gum inflammation and infection around the implant. The reports list no deaths and 1,524 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
- 1,532
- Deaths reported
- 0
- Injuries reported
- 1,532
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,532 adverse event reports that list this exact device (DI 07630031743367), received between Aug 25, 2020 and Sep 28, 2026 — classified as 1,532 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,155 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 Osseointegrate1,155
- Loss of Osseointegration197
- Adverse Event Without Identified Device or Use Problem151
- Difficult to Insert24
- Separation Failure4
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions788
- Fibrosis494
- Unspecified Infection261
- Pain258
- Inflammation115
- Hemorrhage/Blood Loss/Bleeding99
- Swelling/ Edema93
- Fistula51
Recent adverse event reports
The 25 most recent of 1,532 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 50920547 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50806855 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739047 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain
MAUDE report 50738617 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: Inflammation; Pain; Swelling/ Edema
MAUDE report 50738554 ↗InjurySep 11, 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. Patient presented with bone type III and fair oral hygiene. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis and Bleeding. No further patient complications were reported.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection
MAUDE report 50737974 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: Inflammation; Pain; Swelling/ Edema
MAUDE report 50737641 ↗InjurySep 11, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2026 in ADA 4. Details of surgery: Implant surface not completely covered with bone. On (B)(6) 2026, loss of osseointegration was verified. Patient presented with inadequate bone quality/quantity and previous bone augmentation. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis and Inflammation. No further patient complications were reported.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 50737608 ↗InjurySep 11, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2025 (b)(6) in ADA 6. Details of surgery: Implant surface not completely covered with bone. On 2026 (b)(6), loss of osseointegration was verified. Patient presented with fair oral hygiene. 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 50737512 ↗InjurySep 11, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 9. On (b)(6) 2026, non-osseointegration 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 50737403 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719625 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719052 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719037 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fistula; Swelling/ Edema; Unspecified Infection
MAUDE report 50655220 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654758 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50654719 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653871 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653867 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653545 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fistula; Swelling/ Edema; Unspecified Infection
MAUDE report 50653106 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50652924 ↗InjuryAug 31, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 13. Details of surgery: Ridge augmentation. On (b)(6) 2026, 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: Peri-implantitis, Pain, Fistula and Inflammation. No further patient complications were reported.
Patient problems: Fistula; Inflammation; Pain; Unspecified Infection
MAUDE report 50529443 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50415420 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50415381 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50415333 ↗
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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