COUGAR 189155616Recalls & reported problems
Medos International Sàrl · COUGAR LS LATERAL CAGE SYSTEM LORDOTIC CAGE 18 x 16 x 55mm, 15 DEGREES · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034356976), received between Feb 26, 2018 and Feb 26, 2018 — 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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
- Not Applicable1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2018Break; Break
CFRP COUGAR LATERAL CAGE ITEM (B)(4) SHEERED/SPLIT UPON IMPLANTING INTO DISC SPACE. THE SURGEON EXPLAINED TO ME AFTER THE CASE THAT THE CAGE APPEARED TO HAVE BEEN CROSS THREADED, HE NOTICED THIS AS HE WAS ATTEMPTING TO DISENGAGE THE CAGE FROM THE INSERTER IT WAS PROVIDING RESISTANCE. HE SAID THE CAGE SPLIT AT ITS MOST FRAGILE SPOT, THE INNER THREADS OF THE CAGE WHERE THE INSERTER ENGAGES THE IMPLANT. HE SAID THAT THERE APPEARED TO BE A CRACK ALONGSIDE THE TI MARKINGS BUT HIS OPINION WAS THAT IT DID NOT SHEER THROUGH THE TI AND THEREFOR HE FELT IT STILL WAS STABLE IN HIS CLINICAL OPINION, AND REMOVING IT COULD HAVE DONE MORE DAMAGE THAN JUST LEAVING IT AND PROVIDING EXTRA FIXATION WITH A CERVICAL PLATE 22MM AND FOUR LARGE DIAMETER 4.0X18MM SCREWS ALONG WITH FOUR PERC VIPER CORTICAL FIX SCREWS POSTERIOR AND TWO RODS. PATIENT CONSEQUENCE? :UNKNOWN. PATIENT CONSEQUENCE DESCRIPTION:NO IMMEDIATE CONSEQUENCE, SURGEON LEFT IMPLANT INSIDE INTERBODY AND SECURED THE SPACE USING A LATERAL PLATE FOR EXTRA SUPPORT AS WELL AS POSTERIOR FIXATION. ACTION TAKEN FOR PROCEDURE:THE SURGEON HAD TO PLACE A LATERAL PLATE WITH 4 SCREWS FOR ADDITIONAL STABILIZATION. IS THE INFORMATION BEING SUBMITTED FOR TH
Patient problems: No Known Impact Or Consequence To Patient; Not Applicable
MAUDE report 7297198 ↗
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- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
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- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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