STRIDE PFSR101004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556627747), received between Apr 21, 2020 and Sep 3, 2020 — classified as 1 injury, 1 malfunction.

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

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 3, 2020Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT AFTER A CORI PROCEDURE, A MESSAGE OF SYSTEM FAULT CRITICAL ERROR WOULD APPEAR AFTER THE SYSTEM WAS SHUT DOWN WERE IT INDICATED THAT THE LAUNCHER EXITED DUE TO A CONFIGURATION ERROR. THE CASE WAS RAN NORMALLY. NO PATIENT WAS INVOLVED AT THE TIME OF THE INCIDENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10487434 ↗
• InjuryApr 21, 2020Break; Break

  IT WAS REPORTED THAT DURING A CASE TODAY WE HAD AN ISSUE WITH TRIALLING THE POLYS. SURGEON SLID IN THE TRIAL POLY AND EACH TIME HE DID SO, IT SEEMED TO ROCK BACK AND FORTH ANTERIOR TO POSTERIOR INSIDE THE TIBIAL TRAY. THIS CAUSED ISSUES TRIALLING OUR FINAL ROM, ESPECIALLY WHEN HE TRIED TO BRING THE LEG INTO FULL EXTENSION WHERE THE POLY WAS PUSHED TO THE POSTERIOR EACH TIME. THE SURGEON KEPT PLAYING WITH POLY TRIALS UNTIL THEY WERE ABLE TO PROPERLY ASSESS THE FIT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9983814 ↗