MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium TL (REF 033.252G)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630031714930), received between Jul 17, 2020 and Nov 8, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 35. ON (B)(6) 2021, 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 12773243 ↗
• InjuryMay 5, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 34. ON (B)(6) 2020, 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 11778234 ↗
• InjuryMay 3, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 15. ON (B)(6) 2020, 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 11764030 ↗
• InjuryMay 3, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 46. ON (B)(6) 2020, 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 11764005 ↗
• InjuryMay 3, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 21. ON (B)(6) 2020, 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 11764001 ↗
• InjuryJul 17, 2020Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2015 IN THE PATIENT'S MOUTH. ON (B)(6) 2020, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE AND BRUXISM. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PERI-IMPLANTITIS, PAIN, MOBILITY AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain; Swelling; Tissue Damage; Unspecified Infection

  MAUDE report 10290470 ↗