LEOPARD 186448011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034119083), received between Jan 25, 2018 and Jan 25, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2018Break; Break

  L5/S1 TLIF DR (B)(6), (B)(6) PRIVATE HOSPITAL (B)(6) 2018. DR (B)(6) WAS PERFORMING A TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) AT L5/S1 WITH THE LEOPARD CAGE, SIZE 11MM. HE HAD PREPARED THE SITE AS PER HIS USUAL METHOD, THE SELECTED CAGE WAS PACKED WITH BONE GRAFT AND HE STARTED TO INSERT THE CAGE IN THE USUAL MANNER. THE CAGE BROKE AT THE END THAT WAS ATTACHED TO THE INSTRUMENT, THE END CLOSEST TO THE SURGEON, NOT INSIDE THE PATIENT. HE REMOVED THE INSTRUMENT AND THE BROKEN PARTS OF THE CAGE, PREPARED THE SITE AGAIN AND THEN INSERTED ANOTHER SIZE 11MM CAGE. SURGEON WAS HAPPY THAT HE HAD REMOVED ALL PARTS OF THE INITIAL CAGE. THERE WAS A MINIMAL DELAY TO THE SURGERY. NO AE TO PATIENT. MALE PATIENT. (B)(6).

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

  MAUDE report 7219549 ↗