CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750016540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169783836), received between Aug 24, 2019 and Oct 26, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2023Malposition of Device; Malposition of Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR FUSION AT TH12-L5 FOR PYOGENIC SPONDYLITIS. IT WAS REPORTED THAT AFTER INSTALLING THE ILIAC REFERENCE FRAME, OARM/NAVI WAS USED TO BEGIN INSERTING THE TH12 SCREW. AFTER INSERTING THE TH12 SCREW, A SENSE OF DISCOMFORT WAS FELT WHEN CREATING THE PILOT HOLE FOR THE TH11 SCREW, SO THE SCREWS WERE INSERTED INTO L4 AND L5 VERTEBRAL BODIES FIRST, AND THEN TRANSFERRED TO THE TH12 AND TH11 SCREWS, BUT IT WAS CHANGED TO A SPINOUS PROCESS REFERENCE, AND THE OARM WAS ROTATED AGAIN. AT THAT TIME, THE SCREW OF TH12 WAS FOUND TO HAVE DEVIATED INTO THE SPINAL CANAL AND WAS REINSERTED. AFTER THAT, THE SCREW WAS INSERTED INTO THE REMAINING VERTEBRAL BODY AND THE SURGERY WAS COMPLETED. PATIENT DEVELOPED LOWER LIMB PARALYSIS. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Paraplegia

  MAUDE report 18009791 ↗
• InjuryAug 24, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH DEGENERATIVE SCOLIOSIS; AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3-L5. O-ARM/NAVIGATION WAS USED IN COMBINATION IN THIS SURGERY. POST-OP, SCREW IMPLANTED AT L3 DEVIATED FROM THE PEDICLE, DUE TO WHICH THE PATIENT GOT PARALYZED. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019, IN WHICH THE DEVIATED SCREW WAS REPLACED. PATIENT'S HOSPITAL STAY WAS PROLONGED BECAUSE OF THE RE-OPERATION. PATIENT'S CURRENT STATUS (AFTER REPLACEMENT SURGERY) IS NOT KNOWN.

  Patient problems: Paralysis

  MAUDE report 8928725 ↗