Straumann® BLC and TLC Implants SLA Roxolid BL (REF 035.9310S)Recalls & reported problems
Institut Straumann AG · BLC Implant, Ø 4.0mm RB, SLActive 10mm, Roxolid · Class 2 · Implant
All models of Straumann BLC and TLC Implants (153)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Straumann BLC dental implant is a screw-shaped implant placed in the jawbone to support a replacement tooth. Its 143 reports mostly describe implants that did not bond with the bone, sometimes not holding at placement, and some mention infection around the implant. There are no deaths and 143 injuries. No recalls name this device. Reports rose to 143 in the last 12 months from 0 before.
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
- 149
- Deaths reported
- 0
- Injuries reported
- 149
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 07630031780089), received between Feb 10, 2026 and Sep 18, 2026 — classified as 149 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (116 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 Osseointegrate116
- Adverse Event Without Identified Device or Use Problem16
- Difficult to Insert9
- Loss of Osseointegration5
- Separation Failure3
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- Fibrosis48
- Unspecified Infection36
- Pain22
- Hemorrhage/Blood Loss/Bleeding8
- Inflammation5
- Swelling/ Edema4
- Fistula3
Recent adverse event reports
The 25 most recent of 149 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825094 ↗InjurySep 18, 2026Difficult to Insert
The clinician reports that the day the implant was placed in ADA 20, failure occurred upon insertion. Details of surgery: Primary stability not achieved, Implant surface not completely covered with bone and Nerve encroachment. 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 50824235 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50807111 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50807110 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806908 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 9, failure occurred upon insertion. Details of surgery: Primary stability not achieved. Patient presented with bone type III and inadequate bone quality/quantity. 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 50806358 ↗InjurySep 17, 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. Patient presented with bone type III and inadequate bone quality/quantity. 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 50806354 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760411 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50759764 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50759652 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50737902 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50737894 ↗InjurySep 10, 2026Separation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719490 ↗InjurySep 10, 2026Separation Failure
The clinician reports that the day the implant was placed in ADA 4, failure occurred upon insertion. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. 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 50718751 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50653561 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50652928 ↗InjurySep 4, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 5. 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 50616997 ↗InjuryAug 31, 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. Patient presented with bone type III, 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 50528135 ↗InjuryAug 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2026 in ADA 5. On (B)(6) 2026 loss of 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 50481415 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 13. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Infection and Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50481269 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 21. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Infection and Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50481260 ↗InjuryAug 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in ADA 5. On (b)(6) 2026, loss of 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 50480380 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 13. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Infection and Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50480306 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 21. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Infection and Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50480298 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50415986 ↗
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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