CD HORIZON® SOLERA® VOYAGER™ Spinal System 54750014540Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169501171), received between Jul 13, 2018 and Jul 13, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS POSTERIOR SPINAL FUSION AT T8-L2 DUE TO T11 FRACTURE DISLOCATION (3A3B). POST-OPERATIVE WOUND INFECTION OCCURRED AND AS A RESULT THE SCREW ON THE RIGHT SIDE BECAME LOOSE. THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF THE SCREW.

  Patient problems: Unspecified Infection

  MAUDE report 7685855 ↗
• InjuryJul 13, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS POSTERIOR SPINAL FUSION AT T8-L2 DUE TO T11 FRACTURE DISLOCATION (3A3B). POST-OPERATIVE WOUND INFECTION OCCURRED AND AS A RESULT THE SCREW ON THE RIGHT SIDE BECAME LOOSE. THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF THE SCREW.

  Patient problems: Failure of Implant; No Code Available; Unspecified Infection

  MAUDE report 7685779 ↗
• InjuryJul 13, 2018Fracture; Loose or Intermittent Connection; Device Dislodged or Dislocated; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS POSTERIOR SPINAL FUSION AT T8-L2 DUE TO T11 FRACTURE DISLOCATION (3A3B). POST-OPERATIVE WOUND INFECTION OCCURRED AND AS A RESULT THE SCREW ON THE RIGHT SIDE BECAME LOOSE. THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF THE SCREW.

  Patient problems: Failure of Implant; Joint Dislocation; No Code Available; Unspecified Infection

  MAUDE report 7685770 ↗
• InjuryJul 13, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS POSTERIOR SPINAL FUSION AT T8-L2 DUE TO T11 FRACTURE DISLOCATION (3A3B). POST-OPERATIVE WOUND INFECTION OCCURRED AND AS A RESULT THE SCREW ON THE RIGHT SIDE BECAME LOOSE. THE PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF THE SCREW.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7685765 ↗