Straumann® BLC and TLC Implants SLA Roxolid TL (REF 035.6210S)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630031765031), received between Mar 19, 2026 and Sep 28, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (9 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Failure to Osseointegrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921803 ↗
• InjurySep 28, 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 50919742 ↗
• InjuryAug 17, 2026Failure to Osseointegrate

  The clinician reports the implant was inserted (b)(6) 2026 in FDI 44. 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 50282509 ↗
• InjuryAug 3, 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 50120146 ↗
• InjuryJul 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. 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 50010338 ↗
• InjuryJul 6, 2026Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6)2026 IN FDI 33. ON (B)(6)2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 25722915 ↗
• InjuryJun 15, 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 25507856 ↗
• InjuryMar 19, 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 24642144 ↗
• InjuryMar 19, 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. 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 24642111 ↗