CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750015550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169783782), received between Jun 12, 2026 and Jun 12, 2026 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION SPINAL THERAPY FOR L1 BURST FRACTURE. IT WAS REPORTED THAT AFTER FIXATION FROM T11/12 TO L2/3, THE L2/3 SCREW BACKED OUT SO THE L2/3 SCREW WAS REPLACED, AND ADDITIONAL SCREWS WERE INSERTED AT T10 AND L4 FOR REFIXATION. ACCORDING TO THE OPINION OF THE SURGEON, THE PATIENT¿S BONE DENSITY WAS BELOW 50. THE PHYSICIAN COMMENTED THAT THE INITIAL SURGICAL PLANNING WAS INSUFFICIENT. BECAUSE THE BONE WAS FRAGILE, IT WAS CONSIDERED UNAVOIDABLE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE INITIAL SURGERY WAS PERCUTANEOUS PEDICLE SCREW: T11/12¿L2/3: L1 BURST FRACTURE VERTEBROPLASTY WAS PERFORMED. FOUR SCREWS AT L2/3 HAD BACKED OUT AND THE FOUR SCREWS WERE UPSIZED AND THE HA STICKS WERE REPLACED. FIXATION WAS EXTENDED TO T10¿L4, RESULTING IN A 3¿3 FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481460 ↗
• InjuryJun 12, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION SPINAL THERAPY FOR L1 BURST FRACTURE. IT WAS REPORTED THAT AFTER FIXATION FROM T11/12 TO L2/3, THE L2/3 SCREW BACKED OUT SO THE L2/3 SCREW WAS REPLACED, AND ADDITIONAL SCREWS WERE INSERTED AT T10 AND L4 FOR REFIXATION. ACCORDING TO THE OPINION OF THE SURGEON, THE PATIENT¿S BONE DENSITY WAS BELOW 50. THE PHYSICIAN COMMENTED THAT THE INITIAL SURGICAL PLANNING WAS INSUFFICIENT. BECAUSE THE BONE WAS FRAGILE, IT WAS CONSIDERED UNAVOIDABLE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE INITIAL SURGERY WAS PERCUTANEOUS PEDICLE SCREW: T11/12¿L2/3: L1 BURST FRACTURE VERTEBROPLASTY WAS PERFORMED. FOUR SCREWS AT L2/3 HAD BACKED OUT AND THE FOUR SCREWS WERE UPSIZED AND THE HA STICKS WERE REPLACED. FIXATION WAS EXTENDED TO T10¿L4, RESULTING IN A 3¿3 FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481459 ↗