CLYDESDALE PTC™ Spinal System 4922245Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CAGE 4922245 CDALE PTC 22MM 12 DEG 12X45 · 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 00643169191334), received between Dec 7, 2017 and Dec 7, 2017 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Damage to Ligament(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AND POSTERIOR SPINAL FUSION (PSF) AT L2-L4. INTRA-OP, SAGITTAL ADJUSTING SCREWS (SAS) WERE USED AT L2 AND L3. MULTI AXIAL SCREWS (MAS) WERE USED AT L4. ROD WAS INSTALLED WITH A QUITE LORDOSIS TO FIX THE CAUDAL SIDE. AFTER THAT, CORRECTION WAS CONDUCTED WITH SEQUENTIAL AND IMAGE WAS CHECKED. THE IMAGE REVEALED THAT ANTERIOR LONGITUDINAL LIGAMENT WAS CUT. IMPLANTED 12MM CAGE WAS REMOVED FROM ANTERIOR AND EXCHANGED WITH 16MM CAGE WHOSE SIZE WAS MORE AND THE SURGERY WAS FINISHED. IT IS UNKNOWN WHETHER LIGAMENT WAS CUT DURING OLIF OR DURING CORRECTION. THERE WAS A OVERALL DELAY OF LESS THAN 60 MIN IN PROCEDURE TIME.
Patient problems: Damage to Ligament(s)
MAUDE report 7094713 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- 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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