CRESCENT™ Spinal System 9393612Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994187772), received between Jan 4, 2018 and Feb 16, 2018 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionFeb 16, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBER INTERBODY FUSION AT L4-L5 DUE TO SOME UNSPECIFIED REASONS. INTRA-OP, AFTER IMPLANTING, THE X-RAY SHOWED THAT THE IMPLANT BROKE WHILE BEING POSITIONED. NO PATIENT COMPLICATIONS OCCURRED DURING THIS EVENT. NO ADDITIONAL SURGERY HAS BEEN PERFORMED AND PLANNED YET. THE SURGEON THOUGHT THE PLACEMENT OF THE GRAFT WAS GOOD AND THAT THE BREAK IN IT WOULD NOT EFFECT THE FUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7276029 ↗
• InjuryJan 4, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 DUE TO LUMBAR SCOLIOSIS. INTRA-OPERATIVELY, THE SPACER BROKE DURING THE IMPLANTATION. NO FRAGMENTS REMAINED INSIDE THE PATIENT'S BODY. AN ALTERNATIVE CAGE OF SMALLER SIZE WAS SUCCESSFULLY PLACED. THE PATIENT HAD PROLONGED HOSPITALIZATION AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7163219 ↗