CD HORIZON® SOLERA® Spinal System 54850015545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169491236), received between Jan 3, 2017 and Jul 28, 2023 — classified as 2 injuries, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A TAB EXTENDER. IT WAS REPORTED THAT THE SCREW TAB WAS LEFT ATTACHED TO THE PEDICLE SCREW DESPITE BREAKING THE TAB EXTENDER AWAY. THERE WAS NO PATIENT INJURY. THE PATIENT WAS BROUGHT BACK TO SURGERY FOR SCREW TAB REMOVAL DURING A SEPARATE ADDITIONAL SURGERY ON (B)(6) 2023 AND THE TAB WAS THROWN AWAY. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17411820 ↗
• MalfunctionMar 18, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THE RAPY. IT WAS REPORTED THAT VOYAGER SCREWS WERE PLACED ALONG WITH THE ROD AND SET SCREWS. ALL SET SCREWS WERE BROKEN OFF/LOCKED DOWN WITH NO ISSUE. SURGEON WENT TO BREAK TAB EXTENDERS USING THE TAB BREAKER, AND THE SCREW HEAD BROKE. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FRAGMENTS LEFT INSIDE THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510509 ↗
• InjuryJan 3, 2017Malposition of Device; Malposition of Device

  PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVELS INVOLVED: L4-5 IT WAS REPORTED THAT INTRA-OP, THE SCREW WENT IN TO ILIAC VEIN. THE GENERAL SURGEON HAD TO GO THROUGH STOMACH TO RETRIEVE THE SCREW. THE PATIENT LOST LOTS OF BLOOD. THE SURGEON HAD TO OPEN THE STOMACH TO RETRIEVE THE SCREW AND STOP BLEEDING.

  Patient problems: Blood Loss

  MAUDE report 6220772 ↗