CRESCENT™ Spinal System 9393008Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994187567), received between Sep 27, 2018 and Jan 5, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH SPACER INVOLVED IN A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE. IT WAS REPORTED THAT IMPLANT BROKE DURING PROCEDURE AND IMPLANTATION PROCESS. LATER, IT WAS TAKEN OUT. PRODUCT CAME IN CONTACT WITH PATIENT. THEIR WAS A DELAY OF ABOUT 1 HOUR IN THE PROCEDURE. PRE-OPERATIVE DIAGNOSIS FOR THE PATIENT WAS LUMBAR DISC HERNIATION. NO ADVERSE EVENT OCCURRED TO PATIENT. THE PATIENT¿S MEDICAL HISTORY INCLUDED LUMBAR DISC HERNIATION. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21075783 ↗
• MalfunctionDec 30, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR FUSION FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE SPACER BROKE INTRA OPERATIVELY. THE SPACER PARTIALLY EXPLANTED AND WILL BE RETURNED. THERE WERE FRAGMENTS OF THE IMPLANTS REMAINED IN THE PATIENT'S BODY. THERE IS NO PLAN OF ADDITIONAL SURGERY OR MEDICAL INTERVENTION TO REMOVE THE FRAGMENTS FROM PATIENT BODY. TRIED TO REMOVE AS MUCH AS POSSIBLE DURING THE SURGERY, AND WOULD NOT PERFORM A SECOND SURGERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21032986 ↗
• MalfunctionDec 28, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT WHICH IS USED IN TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SPINAL THERAPY FOR L45 HERNIATED DISC AND LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT THE CAGE WAS BROKEN. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031497 ↗
• MalfunctionOct 3, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 DUE TO DEGENERATIVE DISC DISEASE. THIS WAS A PATIENT UNDER 40S WITH HARD BONE IN A SMALL DISC SPACE. INTRA-OP, IMPLANT WAS PLACED WELL BUT THEN THE SURGEON NOTICED A SMALL PORTION OF TIP OF IMPLANT STUCK TO SECONDARY IMPACTOR. APART FROM THE PORTION OF THE BROKEN TIP, THE PRODUCT REMAINS IMPLANTED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9149767 ↗
• MalfunctionOct 16, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE DISC DISEASE, STENOSIS LEVELS IMPLANTED: L3/4 IT WAS REPORTED THAT POST-OP, INTERBODY FUSION DEVICE PARTIALLY FRACTURED UPON IMPACTION WHICH WAS INDICATED BY POST OP IMAGES. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7968604 ↗
• MalfunctionOct 1, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE DISC DISEASE, STENOSIS PROCEDURE USED: TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVELS IMPLANT: '5/1' IT WAS REPORTED THAT INTRA-OP, THE CAGE FRACTURED UPON INSERTION AND IT WAS REPLACED WITH THE CAGE OF SAME CATALOG NUMBER AND LOT. THE IMPLANT BROKE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7921696 ↗
• MalfunctionSep 27, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL STENOSIS AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION. DURING SURGERY, THE PRODUCT BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE BROKEN IMPLANT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7916870 ↗