CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750016550Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169783850), received between May 21, 2019 and Dec 1, 2023 — classified as 3 injuries, 1 malfunction.

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

• InjuryDec 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR LCS. PROCEDURE PERFORMED WAS OLIF THERAPY. THE LEVEL AT WHICH THE IMPLANT PERFORMED WAS L3/4/5. IT WAS REPORTED THAT THE CAGE CAME OUT, SO IT WAS INSERTED AGAIN. TWO INTERVERTEBRAL OLIF WAS PERFORMED ON (B)(6), 2023. INSERTED CAGE INTO L3/4 AND DD WAS INSERTED IN L4/5. THE REAR PART WAS FIXED WITH V5. THE AG FOR L3/4 CAME OUT, AND THE L3 SCREW LOOSENED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. PATIENT NEED TO BE HOSPITALIZED OR STAY LONGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18244546 ↗
• InjuryDec 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR LCS. PROCEDURE PERFORMED WAS OLIF THERAPY. THE LEVEL AT WHICH THE IMPLANT PERFORMED WAS L3/4/5. IT WAS REPORTED THAT THE CAGE CAME OUT, SO IT WAS INSERTED AGAIN. TWO INTERVERTEBRAL OLIF WAS PERFORMED ON (B)(6), 2023. INSERTED CAGE INTO L3/4 AND DD WAS INSERTED IN L4/5. THE REAR PART WAS FIXED WITH V5. THE AG FOR L3/4 CAME OUT, AND THE L3 SCREW LOOSENED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. PATIENT NEED TO BE HOSPITALIZED OR STAY LONGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18244537 ↗
• InjurySep 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH SCREWS IN A 2-2 FIXED PPS FOR L4 RUPTURE FRACTURE (SUSPECTED META) AND EXPLANTED IN A TOP EXTENSION FOR A COMPRESSION FRACTURE AT L2-S. IT WAS REPORTED THAT THE SCREWS BACKED OUT. IT WAS LOOSENED AND LOCKED IN THE LEFT HAND SIDE OF L2 BUT IN THE RIGHT SIDE OF L2 AND BOTH SIDES OF L3 HAVE LOOSENED, SO THE 4 OF IT WERE SIZED UP AND REPLACED. SCREW WAS ADDED TO TH12/L1, ALL OF WHICH WERE CONCURRENTLY USED WITH HA STICK. THE ROD WAS FASTENED IN THE TH12-S. BONE TRANSPLANT WAS PERFORMED USING LOCAL BONE +GR. THERE WAS NO IMPACT ON PATIENT. THE DATE OF IMPLANT WAS (B)(6) 2022 AND DATE OF EXPLANT WAS (B)(6) 2022. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15444773 ↗
• MalfunctionMay 21, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SCREW FIXATION SURGERY AT L2, L3 DUE TO COMPRESSION FRACTURE. INTRA-OP, THE SCREW HEAD WAS PARTIALLY BROKEN WHEN BREAKING OFF THE SET SCREW PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8627032 ↗