CLYDESDALE PTC™ Spinal System 4922455Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169191266), received between Oct 31, 2018 and Mar 2, 2025 — classified as 3 malfunctions.

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

• MalfunctionMar 2, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN LUMBAR LA TERAL FIXATION SURGERY. IT WAS REPORTED THAT WHILE ATTACHING THE CAGE TO THE INSERTER, IT COULD NOT BE ATTACHED DUE TO IDLING. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT REPORTED CAGE WAS NOT BROKEN AND NOT USED ON THE PATIENT. THERE IS NO ALLEGATION/MALFUNCTION ASSOCIATED WITH THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21500920 ↗
• MalfunctionJul 3, 2024Material Deformation; Mechanics Altered; Material Deformation; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2/3/4 OLIF DUE TO L3 COMPRESSION FRACTURE. IT WAS REPORTED THAT THE CAGE WAS ATTACHED TO THE INSERTER, BUT IT COULD NOT BE CONNECTED IDLING AS THE SCREW WAS STRIPPED, SO IT WAS REPLACED WITH ANOTHER ONE. THERE WAS A DELAY OF LESS THAN 60 MINS REPORTED. 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 19663261 ↗
• MalfunctionOct 31, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR CANAL STENOSIS AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AND POSTERIOR FUSION WITH PERCUTANEOUS PEDICLE SCREW FIXATION AT L3-5. DURING THE SURGERY, THE CAGE BROKE. WHEN REMOVING THE INSERTER AFTER THE CAGE WAS INSERTED TO L3-4, IT WAS NOTICED THAT THE CAGE WAS BROKEN AND REMOVED THE BROKEN PART ONLY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENTS OF THE BROKEN PART REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED DURING THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8026398 ↗