CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850016540Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169768260), received between Nov 4, 2022 and Sep 29, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Mechanics Altered

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Spinal therapy. It was reported that the set screw had difficulty passing through the upper inner threads of the tulip, and the operation time was extended. Several set screws were attempted. The screw was explanted and replaced. There were no patient symptoms or complications have been reported as a result of this event. Additional information received from the manufacturer representative that the procedure involved was Transforaminal Lumbar Interbody Fusion to L4/5. Additional information received from the manufacturer representative that the delay occurred is less than 60 minutes.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928257 ↗
• InjuryNov 2, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A SPINAL THERAPY. IT WAS REPORTED THAT THE SCREWS BROKE AND THE PATIENT HAD TO BE REOPERATED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18053216 ↗
• InjuryJan 13, 2023Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PRODUCT WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156318 ↗
• InjuryJan 13, 2023Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PRODUCT WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156306 ↗
• InjuryNov 4, 2022Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PERCUTANEOUS SP INE SURGERY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT ON (B)(6) 2022, AT THE CAFAM 93 CLINIC, 1-LEVEL PERCUTANEOUS SPINE SURGERY WAS STARTED ON THE PATIENT (B)(6), TWO 10-MM PAK-TYPE GUIDES WERE PASSED TO TAKE THE PEDICLES WHERE TAKING THEM IS DIFFICULT. SINCE THEY WERE NOT WELL VISUALIZED, THE NITINOL GUIDES ARE PASSED TO BE ABLE TO PLACE THE SCREWS, DR. (B)(6) TELLS ME THAT THE SCREWS TO BE PLACED MUST BE 6.5X 40MM REF 55850016540, ONCE ALL THE SCREWS HAVE BEEN PLACED, PROCEED TO MEASURE THE BAR, IT IS CUT, FOLDED AND PLACED IN THE SCREWS, IT IS VERIFIED THAT THE BAR IS INSIDE THE HEAD OF THE SCREWS, THE FIRST STOP REF 6540530 IS PLACED, WHICH ENTERS NORMALLY WHEN PLACING THE SECOND STOP, IT ENTERS WITH DIFFICULTY IS VERIFIED BY X-RAYS THE POSITION OF THE BAR, THIS IS POSITIONED MAKING THE STOP ENTERS, THE FIRST STOP IS FRACTURED, THIS FRACTURES NORMALLY WHEN FRACTURING THE SECOND, IT DOES NOT FRACTURE AND THE STOP IS TRANS-THREADED, IT IS CHANGED STOP AND THIS IS ALSO CROSS-THREADED AND DOES NOT ALLOW IT TO FRACTURE, THE SURGEON IS SUGGESTED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15731555 ↗