CD HORIZON® Spinal System 5440230Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SET SCREW 5440230 4.75 TI NS RED BRK OFF · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994955814), received between Jan 11, 2018 and Jun 10, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (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
- Failure to Align2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2020Failure to Align; Failure to Align
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR SPONDYLOLISTHESIS; AND UNDERWENT RESTORATION OF SPONDYLOLISTHESIS AND REMOVAL OF LUMBAR DISC NUCLEUS PULPOSES. INTRA-OP, AFTER THE SET SCREW WAS PULLED, IT WAS FOUND TO BE SLIPPED. HENCE, THIS SET SCREW WAS COMPLETELY EXPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10139119 ↗MalfunctionJan 11, 2018Failure to Align; Failure to Align
IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH LUMBAR SLIPPAGE AND UNDERWENT REPOSITION AND FIXATION OF LUMBAR SLIPPAGE, INTRA-OP, THE SET SCREW WAS SLIPPED. NO FRAGMENTS OF BROKEN PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7181545 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page