CLYDESDALE PTC™ Spinal System 4926250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169191129), received between Jul 13, 2022 and Oct 14, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2024Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3-4, L4-5 LATE RAL INTERBODY FUSION FOR AN INDICATION OF DEGENERATIVE DISC DISEASE WITH SPONDOLOLYSTHESIS L3-5. IT WAS REPORTED THAT WHILE ATTEMPTING TO THREAD THE CAGE INTO THE INSERTER, IT WAS NOT LOADING PROPERLY AND WAS DEEMED NOT SUITABLE. THE IMPLANT WAS REPLACED WITH A NEW IMPLANT OF THE SAME SIZE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20437299 ↗
• MalfunctionAug 5, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE BROKE OFF NEAR INSERTER DURING INSERTION AND IT WAS PULLED OUT OF THE DISC SPACE SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19904411 ↗
• MalfunctionAug 12, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING FEW CLYDESDALE PTC¿ CAGES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT CAGE HAD BREAKOFF AT THE SAME PLACE FOR THE LAST 4 CASES. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215940 ↗
• MalfunctionJul 13, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN A L4/L5 OLIF (STANDARD PROCEDURE WITH O-ARM NAVIGATION) FOR AN L4/5 LUMBAR SPONDYLOLISTHESIS OF 1 LEVEL. IT WAS REPORTED THAT THE FRAGMENT, WHICH WAS PART OF THE CAGE THAT IS CONNECTED TO THE CAGE INSERTER, BROKE OFF. THE CAGE WAS FOUND TO BE BROKEN AFTER IMPACTION INTO PLACE WITH THE CAGE INSERTER BY HAMMER AND DURING THE ORTHOGONAL CAGE POSITIONING. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE DATE OF IMPLANT IS (B)(6)2022. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14998458 ↗