CD HORIZON® SOLERA® Spinal System X0914079Recalls & reported problems
Medtronic Sofamor Danek, Inc. · ROD X0914079 DUAL BEND 5.5 CCM L 400MM · Class 2 · Implant
All models of CD HORIZON SOLERA Spinal System (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169652767), received between May 1, 2019 and May 1, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K113174); they may or may not involve this specific model.
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
- Break2
Patient problems
- Failure of Implant2
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY AT T5-PELVIS, IN WHICH THE RODS WERE IMPLANTED. ON AN UNKNOWN DATE, POST-OP, THE ROD BROKE. ALLEGEDLY, THE PATIENT ALSO SUFFERED WITH BACK PAIN AND NON-FUSION DUE TO BREAKAGE OF ROD. HENCE, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY, WHEREIN THE BROKEN ROD WAS EXPLANTED.
Patient problems: Failure of Implant; Pain
MAUDE report 8568206 ↗InjuryMay 1, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY AT T5-PELVIS, IN WHICH THE RODS WERE IMPLANTED. ON AN UNKNOWN DATE, POST-OP, THE ROD BROKE. ALLEGEDLY, THE PATIENT ALSO SUFFERED WITH BACK PAIN AND NON-FUSION DUE TO BREAKAGE OF ROD. HENCE, ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY, WHEREIN THE BROKEN ROD WAS EXPLANTED.
Patient problems: Failure of Implant; Pain
MAUDE report 8568200 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K113174. One submission often covers many models, so check the product and lot details in each record.
- Z-2603-2018 · Jul 9, 2018 · TerminatedMedtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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