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MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS SLActive Titanium TL (REF 033.253G)Recalls & reported problems

Institut Straumann AG · Standard Plus Implant D 4.8mm RN, SLActive® 12mm, Ti guided · Class 2 · Implant

All models of MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS (20)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630031714954), received between May 5, 2021 and May 5, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

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

Device problems

  • Failure to Osseointegrate1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 5, 2021Failure to Osseointegrate; Failure to Osseointegrate

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 26. ON (B)(6) 2020 ON-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 11778267 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

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Sources and updates

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