Crescent Spinal System Titanium X0310662Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994880239), received between Jan 9, 2017 and Jan 9, 2017 — 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.

• MalfunctionJan 9, 2017Crack; Crack

  PRE-OP DIAGNOSIS: LUMBAR STENOSIS WITH DEGENERATIVE DISC DISEASE PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVEL IMPLANTED: L5-S1 IT WAS REPORTED THAT DURING SURGERY, THE CAGE CRACKED ONCE IT WAS TAMPED INTO THE DISC SPACE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6232241 ↗
• MalfunctionJan 9, 2017Break; Break

  IT WAS REPORTED THAT PATIENT WITH LUMBAR STENOSIS AND DEGENERATIVE DISC DISEASE UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE AT L5-S1. INTRA-OP, CAGE CRACKED WHEN INSERTER WAS MALLETED. CAGE BROKE INTO FRAGMENTS. NO FRAGMENTS OF THE PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6232188 ↗