Tiger Shark System S-PT35-32116Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840996173131), received between Apr 29, 2024 and Apr 29, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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

Recent adverse event reports

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

• MalfunctionApr 29, 2024Migration; Migration

  ON 11 MAR DR. (B)(6) IMPLANTED A TIGERSHARK STRAIGHT CAGE, HOWEVER ON THE PATIENT FOLLOW-UP -COMPLAINT OF PAIN- IT WAS DETERMINED THAT THE CAGE HAD MIGRATED AND RETROPULSED. DR.(B)(6) PUT TOGETHER A REVISION PLAN OF EITHER PUSHING THE CAGE BACK IN IF THE CAGE WAS THOUGHT TO HOLD THIS TIME OR TO EXPLANT AND PUT IT IN THE LARGEST CAGE HE COULD GET INTO THE SPACE. REVISION ON 27 MARCH- EX-PLANTED THE OLD CAGE DUE TO CAGE MOBILITY AND REPLACED IT WITH A 14H CAGE. DR. (B)(6) WAS STRUCK WITH HOW POOR THE PATIENT'S BONE WAS AND LARGELY HELD RESPONSIBLE FOR HAVING TO COME BACK IN AND MOVE/EXPLANT THE ORIGINAL CAGE. ASIDE FROM THIS ISSUE, THERE WERE NO OTHER DELAYS, HARM, OR COMPLAINTS ASSOCIATED WITH THIS FFR. THIS ALSO LED ME TO ASK WHY A TIGERSHARK CAGE MAY MIGRATE, AND (B)(6) POINTED OUT THAT OVER PACKING THE CAGE COULD ACT AS A COUNTER TO THE ROUGHENED SURFACE OF TIGERSHARK. I SPOKE WITH (B)(6) TO KEEP AN EYE OUT FOR THIS AS A HEADS-UP, BUT BASED ON WHAT I'VE BEEN TOLD, I DON'T BELIEVE THIS WAS THE ISSUE THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19201009 ↗