CD HORIZON® SOLERA® VOYAGER™ Spinal System 6541101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000211196), received between Jan 5, 2023 and May 27, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2024Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLIF FOR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT SET SCREWS DISLODGED AND REPLACEMENT SURGERY OCCURRED. THE SCREWS WERE LOOSE AND REPLACED. 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 19402430 ↗
• InjuryMay 6, 2024Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SCREWS IN A POSTERIOR PEDICLE SCREW FIXATION WITH CEMENTED SCREWS AT L4/5 FOR BACK PAIN, RADICULAR SYMPTOMS. IT WAS REPORTED THAT THE LOCKING CAP OF THE FNS SCREW WAS TORQUED OFF AND THE BROKEN OFF PART WAS REMOVED. HOWEVER, THE LOCKING CAP HAS COME LOOSE AND IS FLOATING IN MUSCLE ABOVE THE CONSTRUCT. THE LOCKING CAP TORQUED OFF AS NORMAL. THE SURGEON FOLLOWED THE STEPS AS NORMAL AND INDICATED. THE FNS SCREW'S LOCKING CAP IS THE SUSPECTED ISSUE BUT THE SET SCREW WAS REPORTED AS WELL AS THE THREADS MAY BE DAMAGED IN THAT TOO. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19246561 ↗
• InjuryJan 5, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN PERCUTANE OUS SPINAL THERAPY FOR BROKEN RODS. IT WAS REPORTED THAT THE SET SCREWS CAME LOOSE FROM THE TULIP HEAD OF THE IMPLANTED SCREW, EVEN THOUGH THE SET SCREWS HAD BEEN IMPLANTED AND TORQUED ONTO THE ROD. THE PATIENT HAD PAIN AND REVISION SURGERY WAS PERFORMED TO EXPLANT THE SET SCREWS AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. THERE IS NO MALFUNCTION ASSOCIATED WITH THE ROD.

  Patient problems: Pain

  MAUDE report 16100865 ↗