CD HORIZON® Spinal System 859-545Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SCREW 859-545 5.5 FIXED ANGLE 5.5X45 TI · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00673978063461), received between Mar 22, 2017 and Nov 26, 2018 — classified as 1 injury, 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Break1
- Device Slipped1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2018Device Slipped; Device Slipped
IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL FRACTURE AND UNDERWENT LUMBAR INTERNAL FIXATION SURGERY. DURING SURGERY, THE SCREW SLIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT REMAINS IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS RESULT OF THIS EVENT. THE PATIENT HAS ACHIEVED SOLID FUSION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8100998 ↗InjuryMar 22, 2017Break; Break
PRE-OPERATIVE DIAGNOSIS: PATIENT WAS SUFFERING FROM BACK PAIN DUE TO COMPRESSION OF CAUDA EQUINA AT THE LEVEL L2 PROCEDURE: "LUMBAR OPEN" IT WAS REPORTED THAT ON UNKNOWN DATE, POST-OP, THE IMPLANTED SCREW BROKE WHICH CAUSED SEVERE BACK PAIN TO THE PATIENT. PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE. ONLY A PORTION OF THE BROKEN SCREW COULD BE EXPLANTED AND LOWER HALF OF THE SCREW STILL REMAINS IN THE PATIENT.
Patient problems: No Code Available; Pain
MAUDE report 6423664 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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