Clydesdale™ Spinal System X0909604Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994704962), received between Dec 20, 2016 and Dec 20, 2016 — classified as 2 malfunctions.

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 18, 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 20, 2016Break; Break

  PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE DISC DISEASE PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION LEVELS: L2-3, L3-4, L4-5 IT WAS REPORTED THAT INTRA-OP, ONE OF THE CAGES BROKE UPON INSERTION. AFTER A LENGTHY ATTEMPT, IT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. PRODUCTS CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6188385 ↗
• MalfunctionDec 20, 2016Break; Break

  PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE DISC DISEASE PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION LEVELS: L2-3, L3-4, L4-5 IT WAS REPORTED THAT INTRA-OP, AFTER A FAILED ATTEMPT OF CAGE PLACEMENT, ANOTHER CAGE WAS THEN ATTEMPTED FOR IMPLANTATION. THE CAGE BROKE BUT WAS IMPACTED ENOUGH INTO THE SPACE THAT IT WAS LEFT IMPLANTED IN ITS BROKEN CONDITION. BROKEN FRAGMENT WAS REMOVED BUT BULK OF IMPLANT WAS LEFT INSIDE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6188384 ↗