COUGAR 189150614Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034356815), received between Nov 18, 2020 and Dec 30, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE COUGAR LS CAGE CRACKED ON IMPACTION. ALSO, SECOND IMPLANT CRACKED ON IMPACTION. IN THIS TIME, THE IMPLANT BROKE SMALL FRAGMENT OFF AND REMAINING CAGE WAS NOT REMOVED. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN IMPACTION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN INSERTION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) COUGAR LS 18X14X50 15-DEG LORD. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122165 ↗
• MalfunctionDec 30, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE COUGAR LS CAGE CRACKED ON IMPACTION. ALSO, SECOND IMPLANT CRACKED ON IMPACTION. IN THIS TIME, THE IMPLANT BROKE SMALL FRAGMENT OFF AND REMAINING CAGE WAS NOT REMOVED. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN IMPACTION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN INSERTION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) COUGAR LS 18X14X50 15-DEG LORD. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122164 ↗
• InjuryNov 18, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CAGE BROKE DURING IMPACTION INTO HARD BONE WHERE THE SPACE WAS EXTREMELY COLLAPSED. SCREWS WERE LATER INSERTED TO BACK UP THE INTERBODY FUSION AND THE SCREWDRIVERS STRIPPED DURING FINAL TIGHTENING ATTEMPTING TO BACK OUT THE SCREWS AND ADJUST THE HEIGHT. NO FRAGMENTS WERE GENERATED. THE CAGE WILL STAY IMPLANTED. THE SURGEON PACKED THE REST OF THE SPACE WITH BONE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN IMPACTION INSTRUMENTS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN INSERTION INSTRUMENTS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) COUGAR LS LATERAL CAGE SYSTEM LORDOTIC CAGE 18 X 14 X 50MM, 15 DEGREES. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10860795 ↗