CD HORIZON® SOLERA® Spinal System 651100045Recalls & reported problems
Medtronic Sofamor Danek, Inc. · ROD 651100045 5.5 CCM PERC ROD 45MM ST · 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
- 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 00643169749986), received between May 19, 2023 and May 19, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SETSCREW, SCREW, AND ROD IN AN L4/5 ONE INTERVERTEBRAL SPACE MIS-PLIF FOR AN L4/5 LCS. IT WAS REPORTED THAT ONLY THE LEFT SIDE ROD CAME OFF IN THE PATIENT. THE IMAGE WAS ALSO CHECKED AND IT SEEMS THAT THE SET SCREW STILL REMAINS BUT ONLY THE ROD GOT DISLODGED. THE PATIENT HAD AN UNCOMFORTABLE WAIST. DURING THE REPEAT SURGERY, NO OBVIOUS MALFUNCTIONS WERE OBSERVED IN THE SET SCREW OR THE SCREW. THE REPORTED PRODUCTS WERE REMOVED DURING A REPEAT SURGERY AND REPLACED WITH A NEW IMPLANT ON (B)(6) 2023. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: Discomfort
MAUDE report 16960012 ↗
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- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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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