CD HORIZON® SOLERA® VOYAGER™ Spinal System 55850046545Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169745261), received between Aug 28, 2023 and Dec 5, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionDec 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT ROBOTICA LLY ASSISTED POSTERIOR SPINAL FUSION AT L4-S1 FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT POST OP IMAGING REVIEW AT FOLLOW UP APPEARS TO SHOW ONE OF THE RODS DISENGAGING FROM THE SCREW TULIP. HOSPITALIZATION WAS NOT PROLONGED. REVISION SURGERY HAS NOT BEEN PE RFORMED OR SCHEDULED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20850371 ↗
• MalfunctionAug 29, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FORL4/5 GRADE 1 SPONDYLOLISTHESIS. PROCEDURE PERFORMED WAS OPEN L4 L5 DECOMPRESSION AND INTERBODY FUSION UTILISING A TRANSFORAMINAL LUMBAR INTERBODY FUSION APPROACH. IT WAS REPORTED THAT DURING A POST OPERATIVE CT SCAN, IT WAS PICKED UP THAT ONE IF THE SCREWS HAD BROKEN INSIDE THE PATIENTS PEDICLE, MID SHAFT OF THE SCREW. THE PATIENT WAS ASYMPTOMATIC AND HAD SHOWN SIGNS OF A FUSION AT L4 L5 ON THE CT. FRAGMENTS LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17647744 ↗
• MalfunctionAug 28, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SCREWS HAVING UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT AT 6 MONTHS POST-OP, THE SCREWS LOOKED GOOD BUT AT 12 MONTH FOLLOW UP BOTH S1 SCREWS WERE BROKEN. SCREW REMAINED IN PATIENT. PROCEDURE INVOLVED IN THIS EVENT WAS L4-S1 POSTEROLATERAL FUSION. THERE WAS NO DELAY IN THE PROCEDURE. THE PRE-OP DIAGNOSIS WAS L4-S1 SPONDYLOLISTHESIS. PATIENT WAS UNDER OBSERVATION AND THERE WAS NO REVISION SURGERY OCCURRED/ PLANNED AT PRESENT. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630467 ↗