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COUGAR 189155508Recalls & reported problems

Medos International Sàrl · COUGAR LS LATERAL CAGE SYSTEM LORDOTIC IMPLANT 18 x 8 x 55mm · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034165387), received between Jun 15, 2018 and Jan 20, 2021 — classified as 2 malfunctions.

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

  • Break2

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1
  • Not Applicable1

Recent adverse event reports

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

  • MalfunctionJan 20, 2021Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINE PROCEDURE PERFORMED ON (B)(6) 2020, A CAGE WAS BROKEN ON INSERTION AND REPOSITIONING STEP. FRAGMENTS WERE GENERATED BUT THEY WERE REMOVED WITHOUT ADDITIONAL INTERVENTIONS. THERE WAS A FIVE (5) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: INSERTION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) COUGAR LS 18X8X55 LORDOTIC. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11205034 ↗
  • MalfunctionJun 15, 2018Break; Break

    COUGAR LS LORDOTIC CAGE, WHILE ON COUGAR LS INSERTER, CRACKED DURING FINAL PLACEMENT OF CAGE. PATIENT CONSEQUENCE? UNKNOWN. ACTION TAKEN FOR PROCEDURE: DOCTOR MADE ATTEMPT TO REMOVE CAGE, UPON SEEING THAT BROKEN PIECE OF THE CAGE WAS WEDGE (NOT MOVING) IN THE DISC SPACE AND WAS WITHIN SAFE PARAMETERS, HE MADE THE DECISION TO KEEP THE COMPLETE CAGE IMPLANTED. CASE PROCEEDED WITHOUT FURTHER INCIDENT. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

    Patient problems: No Consequences Or Impact To Patient; Not Applicable

    MAUDE report 7607127 ↗

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Sources and updates

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