Straumann® BLC and TLC Implants SLA Roxolid BL (REF 035.8012S)Recalls & reported problems
Institut Straumann AG · BLC Implant, Ø 3.3mm RB, SLA® 12mm, 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 implant has 98 adverse event reports, with no deaths and 98 injuries. Most describe implants that did not osseointegrate, leading to mobility, pain, infection or fibrosis. Reports rose from 1 in the prior 12 months to 97 in the most recent 12 months. 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
- 117
- Deaths reported
- 0
- Injuries reported
- 117
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 07630031764096), received between Oct 15, 2025 and Sep 28, 2026 — classified as 117 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (94 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 Osseointegrate94
- Adverse Event Without Identified Device or Use Problem16
- Loss of Osseointegration4
- Difficult to Insert3
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- Fibrosis35
- Unspecified Infection30
- Pain20
- Hemorrhage/Blood Loss/Bleeding8
- Abscess6
- Swelling/ Edema5
- Inflammation4
Recent adverse event reports
The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Abscess; Unspecified Infection
MAUDE report 50921505 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Hyperresponsive to stimuli; Hypersensitivity/Allergic reaction; Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50921144 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50920706 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Abscess; Unspecified Infection
MAUDE report 50918749 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 23. Details of surgery: Ridge augmentation and Immediate extraction site. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III, fair oral hygiene and inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Pain, Swelling, Increased Sensitivity, Hypersensitivity and Inflammation. No further patient complications were reported.
Patient problems: Hyperresponsive to stimuli; Hypersensitivity/Allergic reaction; Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50918733 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807007 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760454 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50759172 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739082 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50738361 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis
MAUDE report 50738114 ↗InjurySep 11, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in ADA 24. On 2026 (b)(6), 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 50737736 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 11, failure occurred upon insertion. Details of surgery: Primary stability not achieved and Immediate extraction site. 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 50737437 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50655222 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Abscess
MAUDE report 50653979 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50653123 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Abscess
MAUDE report 50653035 ↗InjuryAug 24, 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. 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 50415631 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 28. Details of surgery: Implant surface not completely covered with bone and Nerve encroachment. 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: Numbness. No further patient complications were reported.
Patient problems: Numbness
MAUDE report 50282832 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 12. 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 50282508 ↗InjuryAug 17, 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. At the event the patient experienced: Peri-implantitis and Pain. No further patient complications were reported.
Patient problems: Pain; Unspecified Infection
MAUDE report 50282277 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025 (b)(6) in the patient's mouth. On 2026 (b)(6), non-osseointegration was verified. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis and Pain. No further patient complications were reported.
Patient problems: Pain; Unspecified Infection
MAUDE report 50282249 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 28. Details of surgery: Implant surface not completely covered with bone and Nerve encroachment. 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: Numbness. No further patient complications were reported.
Patient problems: Numbness
MAUDE report 50281099 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in FDI 42. On 2026(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 50258893 ↗InjuryAug 13, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50239070 ↗
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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