CD HORIZON® Spinal System 7226545Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CDH 7226545 LEGACY PEEK 6.5X45 · Class 2 · Implant
All models of CD HORIZON Spinal System (342)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074362908), received between Mar 10, 2017 and Oct 1, 2019 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (3 reports).
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 16, 2026.
Most reported problems
Device problems
- Break3
Patient problems
- No Known Impact Or Consequence To Patient2
- No Code Available1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2019Break; Break
DURING THE REVISION SURGERY, REMOVAL OF PREVIOUS INSTRUMENTATION AND RE-FUSION WAS PERFORMED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9139488 ↗InjuryOct 1, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2016, THE PATIENT UNDERWENT L4-L5 STABILIZATION AND L5-S1 FUSION DECOMPRESSION, IN WHICH THE RODS AND SCREWS WERE IMPLANTED. ON AN UNKNOWN DATE, POST-OP, THE REPORTED SCREW AT S1 BROKE. THE PATIENT ALSO SUFFERED FROM ADJACENT LEVEL DEGENERATION. HENCE, ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED, IN WHICH THE HEAD OF THE SCREW WAS REMOVED WHILE THE TIP REMAINS IMPLANTED IN PATIENT'S S1 VERTEBRA. NO INJURY TO THE PATIENT HAS BEEN REPORTED AFTER THE REVISION SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9139461 ↗InjuryMar 10, 2017Break; Break
PRE-OPERATIVE DIAGNOSIS: L4-5 INSTABILITY DUE AUTOMOBILE ACCIDENT PROCEDURE: REVISION LUMBAR FUSION LEVELS IMPLANTED: L4-5 IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE PATIENT MET WITH AN AUTOMOBILE ACCIDENT. AS A RESULT OF THIS, THE IMPLANTED SCREWS WERE BROKEN AND THE PATIENT SUFFERED WITH BACK PAIN. THE PATIENT HAD UNDERGONE REVISION SURGERY ON FOR REMOVAL OF BROKEN SCREWS AND REPLACEMENT OF THESE SCREWS WITH 'HA' SCREWS SUPPLEMENTED WITH BONE CEMENT.
Patient problems: No Code Available; Pain
MAUDE report 6394385 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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