CRESCENT™ Spinal System 9392508Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994187468), received between Jan 9, 2018 and Dec 11, 2019 — classified as 2 malfunctions.

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

Recent adverse event reports

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

• MalfunctionDec 11, 2019Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR SPINAL CANAL DECOMPRESSION POSTERIOR FIXATION FUSION AT L4-5, S1 DUE TO SPINAL STENOSIS. INTRA-OP, SPACER WAS DEFORMED AT THE CONNECTION SITE AND FRACTURED DURING IMPLANTATION. NO ANY FRAGMENTS OF THE IMPLANT REMAINING IN THE PATIENT BODY. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9449517 ↗
• MalfunctionJan 9, 2018Break; Break

  PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVEL: L5-S1 IT WAS REPORTED THAT DURING SURGERY, THE CAGE BROKE UPON INSERTION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7174360 ↗