CD HORIZON® SOLERA® Spinal System 654100045Recalls & reported problems
Medtronic Sofamor Danek, Inc. · ROD 654100045 5.5 TI AL PERC ROD 45MM ST · Class 2 · Implant
All models of CD HORIZON SOLERA Spinal System (34)
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 00643169749702), received between Sep 15, 2025 and Sep 15, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
Patient problems
- Headache1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM REGULATORY BODY (RB), HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED IN SPINAL THERAPY FOR SPONDYLOLISTHESIS. IT WAS REPORTED THAT POST ARTHRODESIS THE ROD PLUG WAS OUT OF THE ROD AND SWIMMING IN THE BODY ON X-RAYS. THE PATIENT HAD HEADACHE AND REVISION SURGERY WAS PERFORMED TO EXPLANT THE DEVICES. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.
Patient problems: Headache
MAUDE report 23053307 ↗
Other Appliance, fixation, spinal intervertebral body devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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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