COUGAR 189150508Recalls & reported problems
Medos International Sàrl · COUGAR LS LATERAL CAGE SYSTEM LORDOTIC IMPLANT 18 x 8 x 50mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034164601), received between Jun 21, 2022 and Jun 21, 2022 — classified as 1 injury.
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
Device problems
- Break1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 2022Break; Entrapment of Device; Break; Entrapment of Device
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN SOUTH KOREA AS FOLLOWS: IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE COUGAR LS IMPLANT DEVICE WAS BROKEN IN HALF BETWEEN THE VERTEBRAL BODIES. ACCORDING TO THE REPORT, THE SURGEON INSERTED THE REMAINING HALF INTO THE BODY TO COMPLETE THE PROCEDURE. IN THIS CASE, THE OPERATING SURGEON WANTS TO MAKE SURE THAT THE FUSION IS NOT AFFECTED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) DEVICE.
Patient problems: Foreign Body In Patient
MAUDE report 14757658 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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