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CLYDESDALE PTC™ Spinal System 4926055Recalls & reported problems

Medtronic Sofamor Danek, Inc. · CAGE 4926055 CDALE PTC 22MM 6 DEG 10X55 · Class 2 · Implant

All models of CLYDESDALE PTC Spinal System (28)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169191167), received between Aug 12, 2022 and Aug 12, 2022 — classified as 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

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • 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 15215930 ↗

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Sources and updates

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