CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750014530Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169501157), received between Apr 30, 2019 and Apr 30, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2019Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  PRE OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: DISLOCATION FRACTURE AT T5-T6 TYPE OF PROCEDURE OR TECHNIQUE USED: T3-T4 AND T6-T7 PERCUTANEOUS PEDICLE SCREW (PPS) FUSION IT WAS REPORTED THAT INTRA-OP, DUE TO UNAVAILABILITY OF 4.5MM X 25MM SCREWS, 4.5MM X 30MM SCREWS WERE INSERTED FORCIBLY USING O-ARM NAVIGATION. AS A RESULT, THE SCREWS ON BOTH SIDES OF T3 PROTRUDED THE ANTERIOR WALL OF THE VERTEBRAL BODY, CAUSING AN EVENT THAT HIT THE LUNG AND THE THORACIC AORTA. NO PATIENT COMPLICATIONS WERE REPORTED BUT IT WAS NEARLY A CATASTROPHE. FINAL TIGHTENING WAS PERFORMED FORCIBLY WITH THE CONSTRUCT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8564176 ↗
• MalfunctionApr 30, 2019Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  PRE OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: DISLOCATION FRACTURE AT T5-T6 TYPE OF PROCEDURE OR TECHNIQUE USED: T3-T4 AND T6-T7 PERCUTANEOUS PEDICLE SCREW (PPS) FUSION IT WAS REPORTED THAT INTRA-OP, DUE TO UNAVAILABILITY OF 4.5MM X 25MM SCREWS, 4.5MM X 30MM SCREWS WERE INSERTED FORCIBLY USING O-ARM NAVIGATION. AS A RESULT, THE SCREWS ON BOTH SIDES OF T3 PROTRUDED THE ANTERIOR WALL OF THE VERTEBRAL BODY, CAUSING AN EVENT THAT HIT THE LUNG AND THE THORACIC AORTA. NO PATIENT COMPLICATIONS WERE REPORTED BUT IT WAS NEARLY A CATASTROPHE. FINAL TIGHTENING WAS PERFORMED FORCIBLY WITH THE CONSTRUCT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8564166 ↗