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CLYDESDALE PTC™ Spinal System 4986655Recalls & reported problems

Medtronic Sofamor Danek, Inc. · CAGE 4986655 CDALE PTC 18MM 6 DEG 16X55 · 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 00643169190566), received between Dec 31, 2018 and Dec 31, 2018 — 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 Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionDec 31, 2018Break; Break

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL STENOSIS AND RADICULOPATHY AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) SURGERY. DURING SURGERY, THE POINT BROKE OFF OF THE CAGE SO IT WAS NO LONGER CONNECTED SECURELY TO THE INSERTER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8205697 ↗

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Sources and updates

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