CD HORIZON® Spinal System 7560020Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SET SCREW 7560020 BREAK OFF SS · Class 2 · Implant
All models of CD HORIZON Spinal System (342)
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 00885074464664), received between Mar 24, 2017 and Mar 24, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Corroded” (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
- Corroded1
Patient problems
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2017Corroded; Corroded
IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY DUE TO SCOLIOSIS ON AN UNKNOWN DATE. POST-OP, THERE WAS SUSPECTED INFECTION AND/OR ALLERGIC REACTION TO THE METAL IN THE PATIENT. HENCE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 TO REMOVE THE HARDWARE. THE HARDWARE WAS IMPLANTED 6 YEARS AGO. WHEN REMOVING THE SET SCREWS, RODS, AND SCREWS THERE WAS A BLACK, ASHY SUBSTANCE AROUND THE METAL. THE SUPERIOR SET SCREWS OF THE CONSTRUCT WERE LOOSE AND ONE APPEARED TO BE CORRODED.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 6430873 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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