CLYDESDALE PTC™ Spinal System 4922060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169191358), received between Nov 28, 2017 and Sep 26, 2022 — 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.

• MalfunctionSep 26, 2022Fracture; Fracture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT WHILE INSERTING THE INNER BODY IT FRACTURED AT THE INSERTER CONNECTION WHILE THE SURGEON WAS IMPLANTING THE IMPLANT. THE INNER BODY WAS NEVER IMPLANTED BECAUSE OF THE FRACTURE. THERE WAS NO INJURY TO THE PATIENT AND BOTH PIECES OF THE INNER BODY WERE RETRIEVED. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15483176 ↗
• MalfunctionNov 28, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY IUSION (OLIF) AT L4/5 DUE TO SPINAL CANAL STENOSIS. INTRA-OP, WHEN THE SURGEON WAS TAPPING THE CAGE WITH HAMMER TO INSERT, BACK PORTION OF THE CAGE BROKE. THE BROKEN PART WAS REMOVED FROM THE PATIENT¿S BODY AND THE OTHER PART WAS LEFT AS IMPLANT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7062560 ↗