COUGAR 287155308Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034360034), received between Aug 31, 2021 and Aug 31, 2021 — classified as 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. 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.

• MalfunctionAug 31, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN EXTREME LATERAL INTERBODY FUSION (XLIF) PROCEDURE AT LEVEL L5/S1, THE LATERAL ANGLED TRIAL BROKE. DURING THE INITIAL TRIALING PHASE, THE TRIAL BROKE AWAY FROM THE SHAFT. THE SURGEON SUCCESSFULLY REMOVED THE BROKEN TRIAL USING A PLIER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) LATERAL ANGLED TRIAL 8 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392140 ↗