CLYDESDALE PTC™ Spinal System 4922445Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CAGE 4922445 CDALE PTC 22MM 12 DEG 14X45 · 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 00643169191280), received between Oct 9, 2017 and Oct 9, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
Patient problems
- Paralysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 9, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
PRE-OP DIAGNOSIS: LUMBAR CANAL STENOSIS PROCEDURE USED: OBLIQUE LUMBAR INTERBODY FUSION (OLIF) LEVELS IMPLANTED: L1-2-3 IT WAS REPORTED THAT POST-OP, THE CAGE AT L2-3 MIGRATED BY ONE-THIRD OF ITS LENGTH TO ANTERIOR DUE TO WHICH PATIENT DEVELOPED PARALYSIS ON LOWER EXTREMITY. REVISION WAS PERFORMED ON (B)(6) 2017. PARALYSIS WAS RESOLVED POST SURGERY.
Patient problems: Paralysis
MAUDE report 6927949 ↗
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- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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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