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STRAUMANN DENTAL IMPLANT SYSTEM SLActive Roxolid TL (REF 033.434S)Recalls & reported problems

Institut Straumann AG · Standard Implant, D 3.3 mm, RN, SLActive 14 mm, Roxolid · Class 2 · Implant

All models of STRAUMANN DENTAL IMPLANT SYSTEM (128)

Data updated Oct 18, 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 07630031715616), received between Sep 12, 2019 and Sep 12, 2019 — 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 18, 2026.

Most reported problems

Device problems

  • Failure to Osseointegrate1
  • Loss of Osseointegration1

Patient problems

  • Hemorrhage/Blood Loss/Bleeding1
  • Pain1

Recent adverse event reports

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

  • InjurySep 12, 2019Failure to Osseointegrate; Loss of Osseointegration; Loss of Osseointegration

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2011 IN FDI 23 OF THE PATIENT'S MOUTH. ON (B)(6) 2019, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

    MAUDE report 9016146 ↗

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Sources and updates

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