CLYDESDALE PTC™ Spinal System 4922260Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CAGE 4922260 CDALE PTC 22MM 12 DEG 12X60 · 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 00643169191303), received between Oct 18, 2021 and Oct 18, 2021 — 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
- Mechanics Altered1
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.
MalfunctionOct 18, 2021Break; Mechanics Altered; Break; Mechanics Altered
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF LUMBAR CANAL STENOSIS (LCS) INVOLVED IN THE REPORTED EVENT. LEVELS IMPLANTED- L3/4. IT WAS REPORTED THAT INTRA-OPERATIVELY, CAGE WAS DAMAGED. PRODUCT WAS USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. CAGE BROKE AND NO BROKEN FRAGMENTS LEFT IN THE PATIENT'S BODY. DELAY WAS LESS THAN 60 MINUTES. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ON (B)(6) 2021, RECEIVED UPDATED INFORMATION THAT THE REPORTED CAGE WAS DAMAGED WHEN IT WAS INSERTED USING CAT # JS1500202 AND JS1500204. IT WAS SAID THAT THE CAUDAL END PLATE OF THE VERTEBRAL BODY HAD BEEN HOLLOWED AND FLOATED. THEREFORE, OPENED A CAGE OF THE SAME SIZE AND CHANGED THE INSERTER FOR DEALING WITH IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12645123 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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