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SMART TOE ST0-16PRecalls & reported problems

Stryker GmbH · Intramedullary Arthrodesis Implant · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252263333), received between Dec 19, 2016 and Dec 19, 2016 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Rupture2

Patient problems

  • Failure of Implant2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 19, 2016Material Rupture

    IT WAS REPORTED BY THE RISK MANAGER, RELATED TO ANSM THAT " ARTHRODESIS ON 2ND TOE, RIGHT AND LEFT. THE PATIENT HAS BEEN EXAMINED 1 MONTH LATER : RUPTURE OF THE 2 IMPLANTS (X-RAY IMAGES). NO CONSEQUENCE BECAUSE THE ARTHRODESIS IS OK."

    Patient problems: Failure of Implant

    MAUDE report 6184986 ↗
  • InjuryDec 19, 2016Material Rupture

    IT WAS REPORTED BY THE RISK MANAGER, RELATED TO ANSM THAT " ARTHRODESIS ON 2ND TOE, RIGHT AND LEFT. THE PATIENT HAS BEEN EXAMINED 1 MONTH LATER : RUPTURE OF THE 2 IMPLANTS (X-RAY IMAGES). NO CONSEQUENCE BECAUSE THE ARTHRODESIS IS OK."

    Patient problems: Failure of Implant

    MAUDE report 6184985 ↗

Other PIN, FIXATION, SMOOTH devices

All PIN, FIXATION, SMOOTH devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.