CLYDESDALE PTC™ Spinal System 4986245Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169190689), received between Mar 17, 2017 and Jun 22, 2018 — 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 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.

• MalfunctionJun 22, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION - OLIF AT L3/4, L4/5. INTRA-OP, DURING HAMMERING WITH GRASPING THE SHAFT PART BELOW THE NUT OF THE INSERTER, A GLOVE WAS CAUGHT IN, AND THE SHAFT COULD NOT MOVE. THE INSERTER WAS REMOVED ONCE, AND THE CAGE WAS REMOVED, BUT THE SHAFT STILL COULD NOT MOVE. ANOTHER INSERTER WAS USED, BUT BECAUSE THE THREAD OF THE CAGE WAS BROKEN AND IT COULD NOT BE GRASPED, A NEW ONE WAS UNPACKED. A SCRUB NURSE MADE THE SHAFT MOVE WITH USING A REMOVER AND THE GLOVE WHICH WAS CAUGHT IN WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7628301 ↗
• MalfunctionMar 17, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT WITH THORACIC OSSIFICATION OF THE YELLOW LIGAMENT AND OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L2/3. INTRA-OP, WHEN SURGEON WAS INSERTING CAGE AT L2/3 USING INSERTER, THE CAGE CAME OFF FROM THE INSERTER. THE SURGEON COULDN'T ADD MORE IMPACT TO THE CAGE, SO THE CAGE WAS REMOVED USING FORCEPS. EXCESSIVE FORCE WAS APPLIED ON INSERTER DURING CAGE INSERTION. THREADS OF THE CAGE WERE SHAVED.THE SURGEON TRIED TO REINSERT THE CAGE BUT COULDN'T INSERT IT. ANOTHER CAGE WAS OPENED AND USED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6412507 ↗