CD HORIZON® Spinal System 7191550Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CDH HA COATED MAS 5.5X50 · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885074465197), received between Dec 19, 2018 and Dec 19, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 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
- Break2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH TRAUMA AND THE VERTEBRA FRACTURED. FOR THE SAME, THE PATIENT UNDERWENT FIXATION SURGERY. POST-OPERATIVELY, THE IMPLANTED SCREW BROKE FROM THE TOP OF THE TULIP. AS A RESULT, A REVISION SURGERY WAS PERFORMED TO EXPLANT THE SCREWS. THE UPPER PART OF THE SCREW WAS EXPLANTED WHILE THE LOWER PART STILL REMAINS IN THE PATIENT'S VERTEBRAL BODY. NO PATIENT COMPLICATIONS WERE REPORTED AFTER THE REVISION SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8177990 ↗InjuryDec 19, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH TRAUMA AND THE VERTEBRA FRACTURED. FOR THE SAME, THE PATIENT UNDERWENT FIXATION SURGERY. POST-OPERATIVELY, THE IMPLANTED SCREW BROKE FROM THE TOP OF THE TULIP. AS A RESULT, A REVISION SURGERY WAS PERFORMED TO EXPLANT THE SCREWS. THE UPPER PART OF THE SCREW WAS EXPLANTED WHILE THE LOWER PART STILL REMAINS IN THE PATIENT'S VERTEBRAL BODY. NO PATIENT COMPLICATIONS WERE REPORTED AFTER THE REVISION SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8177983 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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