CRESCENT™ Spinal System 9393608Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994187703), received between Apr 13, 2018 and Oct 26, 2020 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionOct 26, 2020Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION FOR SPINAL THERAPY SUGGESTED FOR TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). EVENT OCCURRED INTRA-OP. LEVELS IMPLANTED L4-5. IT WAS REPORTED THAT THERE WAS A BREAK IN INSTRUMENT AND FRAGMENTS WERE LEFT IN PATIENT. LEFT THE CAGE IN THE DISC SPACE REASONABLY PLACE AND WOULD LIKELY FUSE. IMPLANT REMAINS IN PATIENT. NO FURTHER SYMPTOMS OR COMPLICATIONS REPORTED. UPDATE 2020-OCT-13 E1(REP); THE CAGE BROKE WHILE IMPLANTING THE TIP WAS ON THE INSERTER, THE REST OF THE IMPLANT 90% OF IT WAS IN THE DISC SPACE SURGEON TAMPED IT IN FURTHER AND WAS HAPPY WITH THE MIDLINE FINAL POSITION OF THE IMPLANT. THE CRESCENT INSERTER DID NOT BREAK THE IMPLANT BROKE. CRESCENT PEEK CAGE WAS A PLANNED PART OF THE PROCEDURE. DECOMPRESS THE LEVEL AND FUSE THE LEVEL. PRE-OP DIAGNOSIS WAS CENTRAL STENOSIS AND A TLIF TO ADDRESS THE PATHOLOGY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10732632 ↗
• MalfunctionApr 13, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-5. INTRA-OP, THE CAGE BROKE DURING INSERTION AT THE L4-5 LEVEL. NO FRAGMENTS OF THE DEVICE REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7430525 ↗