CD Horizon® Spinal System 1603300500Recalls & reported problems
Medtronic Sofamor Danek, Inc. · ROD 1603300500 6.0 TICP4 S STR LN 500MM · 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 00643169026278), received between Apr 30, 2025 and Apr 30, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REMOVED AND RE POSITIONING THE ROD AND SCREW SPINAL THERAPY. LEVELS IMPLANTED WERE TH12-S2. INITIAL SURGERY HAPPENED ON (B)(6) 2021 AND THE PROCEDURE WAS POSTERIOR CORRECTION AND FIXATION. LEVELS IMPLANTED WERE TH5-IL. IT WAS REPORTED THAT THE SET SCREW, CROSS-LINK, AND MRC WERE REMOVED, AND THE ROD WAS CUT WITH A METAL CUTTER BETWEEN LT.TH12/L1 AND RT.TH11/TH12 TO REMOVE THE BROKEN ROD. THE L1-IL SCREW WAS REMOVED AND REINSERTED, EXTENDING FROM L1 TO S1, WITH AN ADDITIONAL SCREW INSERTED IN S2. THE ROD WAS REPOSITIONED, AND THE MRC WAS USED FOR VERTICAL CONNECTION TO THE UPPER ROD. THE SATELLITE ROD WAS EXTENDED FROM S2 AND CONNECTED HORIZONTALLY USING THE MRC. FINALLY, THE CROSS-LINK WAS INSTALLED. UNKNOWN PATIENT SYMPTOMS WERE REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932189 ↗
Other Thoracolumbosacral pedicle screw system 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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