CD HORIZON® SOLERA® Spinal System 641100040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169501447), received between Apr 15, 2019 and Apr 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2019Migration; Migration

  PRE-OPERATIVE DIAGNOSIS- LUMBAR FORAMINAL STENOSIS WITH DISC DISORDER PROCEDURE- POSTERIOR LUMBAR INTERBODY FUSION(PLIF) LEVELS IMPLANTED- L5/S IT WAS REPORTED THAT THE ROD WAS INSERTED WITH PERCUTANEOUS PEDICLE SCREW TECHNIQUE, BUT THE POSTOPERATIVE X-RAY IMAGE SHOWED THAT THE ROD WHICH WAS ON THE RIGHT CRANIAL SIDE CAME OFF FROM THE SCREW AND REVISION SURGERY WAS PERFORMED IMMEDIATELY. THERE WAS A DELAY OF LESS THAN A 60 MINUTES AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED DURING THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8513541 ↗