CRESCENT™ Spinal System 9392507Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994187451), received between Nov 5, 2018 and Nov 20, 2020 — 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.

• MalfunctionNov 20, 2020Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE SURGEON USED THE MALLET ON THE INSERTER TWICE FOR THE FINAL PLACEMENT, THEN THE IMPLANT WAS BROKEN INTO PIECES. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PRODUCT CAME IN CONTACT WITH PATIENT AND NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. THERE WAS NO INJURY AND COMPLICATIONS ASSOCIATED WITH PATIENT. THERE WAS NO IMPLANTATION OR EXPLANTATION WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10874130 ↗
• MalfunctionNov 5, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH HERNIATED INTERVERTEBRAL DISC AND UNDERWENT SPINAL DECOMPRESSION SURGERY. DURING SURGERY, THE SPACER WAS BROKEN. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE BROKEN SPACER REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8036729 ↗