CD HORIZON® Spinal System 7191545Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CDH 7191545 HA COATED 5.5X45 · 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
- 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 00885074465180), received between Apr 24, 2017 and Oct 4, 2018 — 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 18, 2026.
Most reported problems
Device problems
- Break3
Patient problems
- No Code Available2
- Pain2
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2018Break; Break
PRE-OPERATIVE DIAGNOSIS: IT WAS A TRAUMA CASE SO THE SURGEON PERFORMED FIXATION. IT WAS REPORTED THAT POST-OP, UPPER HALF OF THE BROKEN SCREW HAS BEEN EXPLANTED AND LOWER HALF OF THE SCREW REMAINED IN VERTEBRAL BODY. REVISION SURGERY WAS PERFORMED AS A RESULT OF THE EVENT.
Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient
MAUDE report 7933241 ↗InjuryApr 24, 2017Break; Break
PROCEDURE: "T/L OPEN" IT WAS REPORTED THAT POST-OPERATIVELY SCREWS WERE BROKEN INSIDE THE PATIENT DUE TO WHICH NERVE ROOTS ARE GETTING COMPRESSED. AS A RESULT OF THIS PATIENT WAS HAVING SEVERE BACK AND LEG PAIN. BROKEN SCREWS WERE EXPLANTED PARTIALLY (80% OF SCREWS REMAINS INSIDE PATIENT) AND FOUR SCREWS WERE USED FOR FIXATION.
Patient problems: No Code Available; Pain
MAUDE report 6515073 ↗InjuryApr 24, 2017Break; Break
PROCEDURE: "T/L OPEN" IT WAS REPORTED THAT POST-OPERATIVELY SCREWS WERE BROKEN INSIDE THE PATIENT DUE TO WHICH NERVE ROOTS ARE GETTING COMPRESSED.AS A RESULT OF THIS PATIENT WAS HAVING SEVERE BACK AND LEG PAIN. BROKEN SCREWS WERE EXPLANTED PARTIALLY(80% OF SCREWS REAINS INSIDE PATIENT) AND FOUR SCREWS WERE USED FOR FIXATION.
Patient problems: No Code Available; Pain
MAUDE report 6515072 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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