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CLYDESDALE PTC™ Spinal System 4986240Recalls & reported problems

Medtronic Sofamor Danek, Inc. · CAGE 4986240 CDALE PTC 18MM 6 DEG 12X40 · 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169190696), received between Oct 1, 2018 and Oct 1, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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

  • Use of Device Problem1

Patient problems

  • Spinal Column Injury1

Recent adverse event reports

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

  • InjuryOct 1, 2018Use of Device Problem; Use of Device Problem

    PRE-OPERATIVE DIAGNOSIS: LUMBAR SPINAL CANAL STENOSIS PROCEDURE USED: OBLIQUE LUMBAR INTERBODY FUSION IT WAS REPORTED THAT INTRA-OP, AFTER THE CAGE WAS INSERTED, THE L2 SUPERIOR ENDPLATE COLLAPSED. THE PHYSICIAN CONFIRMED COLLAPSE BY THE INTRA-OPERATIVE PERSPECTIVE IMAGE ON THE SPOT. NO ADDITIONAL SURGERY WAS PERFORMED. THE CAGE CAME IN CONTACT WITH THE PATIENT AND DID NOT BREAK.

    Patient problems: Spinal Column Injury

    MAUDE report 7921654 ↗

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Sources and updates

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