CLYDESDALE PTC™ Spinal System 4926450Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169190788), received between Feb 13, 2017 and Aug 4, 2024 — classified as 1 injury, 1 malfunction.

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 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.

• MalfunctionAug 4, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE OBLIQUE LATERAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE GRAFT STARTED TO BREAK, WHERE IT IS ATTACHED TO THE INSERTER. THE CLYDESDALE PTC 14X50MM GRAFT WAS ABOUT HALF WAY INTO THE INTERBODY SPACE AT L4/5. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19902536 ↗
• InjuryFeb 13, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON: (B)(6) 2015: THE PATIENT PRESENTED WITH A COMPLAINT OF BACK PAIN. ON (B)(6) 2015: THE PATIENT PRESENTED WITH PRE-OP DIAGNOSIS: LUMBAR DEGENERATIVE DISC (L3-L4) AND UNDERWENT THE FOLLOWING PROCEDURES: OBLIQUE APPROACH FOR ANTERIOR LUMBAR INTERBODY FUSION, L3-L4 WITH DISCECTOMY AND SUBSEQUENT PLACEMENT OF PEEK CAGE, 14 MM X 50 MM X 22 MM WITH 6 DEGREE LORDOSIS PACKED WITH PUTTY AND SUBSEQUENT INSTRUMENTATION WITH A 40 MM STRAIGHT PLATE. AS PER OP-NOTES, ¿..WE THEN WENT ON THE SIZE WITH TEMPLATES AND THEN SUBSEQUENTLY PLACED A PEEK CAGE 14 MM X 50 MM X 22 MM WITH 6 DEGREE LORDOSIS PACKED WITH PUTTY. THEN A 40 MM STRAIGHT PLATE WAS PLACED AFTER 5.5 X 35, TWO BOLTS WERE PLACED, ONE INTO THE L2 AND ONE AT L3 AND THEN 2 HEX NUTS WERE PLACED OVER THE DEVICE ANCHORING IN PLACE. WE THEN ALLOWED THE SOFT TISSUE FALLBACK TOGETHER AFTER REMOVAL OF OUR RETRACTOR.¿ THE PATIENT ALSO UNDERWENT THE FOLLOWING PROCEDURE: LATERAL LUMBAR INTERBODY FUSION WITH CAGE ALLOGRAFT AND ANTEROLATERAL PLATE L3-L4 FOR DEGENERATIVE DISC. AS PER OP-NOTES, ¿..WE THEN PREPARED FOR DISC REMOVAL AND FUSION. WE THEN USED A SERIES OF CURETTES TO DISSECT AWAY THE CARTILAGINOUS END PLATE AND FINALLY

  Patient problems: No Code Available; Pain

  MAUDE report 6325048 ↗