COUGAR 187105108Recalls & reported problems
Depuy Spine, LLC · COUGAR SYSTEM SMALL IMPLANT 8mm, 5 DEGREES · Class 2 · Implant
- 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 10705034135342), received between Sep 29, 2017 and Sep 29, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Torn Material” (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
- Torn Material1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2017Torn Material; Torn Material
ANTERIOR SCOLIOSIS. 173205110 ALIF CAGE SMALL 5DEGREE 10MM THIS ITEM BROKE AS IT WAS POSITIONED IN THE PATIENT AND THEN REMOVED. ALL PIECES OF THE IMPLANT WERE OBTAINED AND DISCARDED BY THE SURGICAL TEAM. A DIFFERENT SIZED CAGE WAS THEN IMPLANTED AT THIS LEVEL OF THE SPINE AND THERE WAS NO DELAY IN SURGERY. 187105108 ALIF CAGE SMALL 5DEGREE 8MM THE THREAD OF THIS ITEM WAS STRIPPED DURING IMPLANTATION WHEN THE INSERTION INSTRUMENT WAS USED TO MANOEUVRE THE IMPLANT INTO POSITION. THE SURGEON NO LONGER NEEDED TO POSITION THE IMPLANT ANY FURTHER AFTER THIS MANOEUVRE AND THEREFORE THE IMPLANT STAYED INSITU AND THERE WAS NO ADDED DELAY IN SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6904203 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.