CD HORIZON® SOLERA® VOYAGER™ Spinal System 55750017545Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169783911), received between Nov 16, 2021 and Feb 4, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L2-5LLIF+PPS (SINGLE POSITION) PROCEDURE IN LEFT LATERAL DECUBITUS POSITION IN A PATIENT DIAGNOSED WITH LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT AFTER COMPLETING THE FINAL CONCLUSION OF THE UPPER SIDE (R), INSERT THE DOWNSIDE (L) ROD. THE PHYSICIAN DECIDED NOT TO USE SV56 COUNTER TORQUE, AVOIDING A LARGE SKIN INCISION, AND THE INSERTER WAS SEQUENTIALLY UNSCREWED FROM THE COUNTER IN A CRANIAL DIRECTION. L2 WAS COMPLETED, AND THE FINAL TIGHTENING OF L3 WAS IDLING. WHEN THE SET SCREW WAS REMOVED AND CHECKED, A BURR APPEARED AND A NEW ONE WAS USED, BUT THE ISSUE REMAINED THE SAME. AS STATED IN THE PROCEDURE MANUAL, THERE WAS NO CHANGE EVEN WHEN COUNTER TORQUE WAS USED. THE SCREW WAS REPLACED WITH A NEW ONE, IMPLYING A POSSIBILITY OF HEAD DEFORMATION OR DAMAGE. AFTER THE REPLACEMENT, THE FINAL TIGHTENING WAS MADE WITHOUT ANY PROBLEMS. THERE WAS A DELAY OF LESS THAN 60 MINS. 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 24256757 ↗
• MalfunctionJan 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW AND SET SCREW IN AN L4/5 VERTEBRA TLIF FOR L4/5 SPONDYLOLISTHESIS. IT WAS REPORTED THAT AFTER THE INCISION CLOSURE, SOMETHING LIKE A NEEDLE WAS STUCK INTO THE HAND. WHEN CHECKING BY PALPATION AFTER THREAD CUTTING AND TAB FOLDING, THE BURR OF THE SET SCREW OR THE SCREW HEAD MAY HAVE BEEN STUCK ON THE GLOVES. IT WAS UNKNOWN IF THERE WERE ANY 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 21228820 ↗
• MalfunctionJul 2, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED SCREW. IT WAS REPORTED THAT, ONE SIDE OF THE TAB WAS BROKEN WHEN ATTEMPTING TO ATTACH THE TAB EXTENDER TO THE V5 SCREW. TH PROCEDURE OR TECHNIQUE PERFORMED WAS L5/S TRANSFORAMINAL LUMBAR INTERBODY FUSION. THERE WAS A TIME DELAY OF 3 MINUTES REPORTED. THE REPORTED SCREW DID NOT CAME IN CONTACT WITH PATIENT BODY. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653204 ↗
• InjurySep 28, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5/S1 TLIF. IT WAS REPORTED THAT THE PATIENT UNDERWENT TLIF ON (B)(6) 2023 AT L5/S1, AND THE CY CAGE CONTRACTED IN AUGUST CAUSING THE GRAFTED BONE TO COMPRESS THE NERVE. THE GRAFTED BONE WAS COMING OUT LIKE A HERNIA AND PRESSING ON THE NERVE, SO THE CAGE WAS REMOVED AND REPLACED WITH MILESTONE IN AN ADDITIONAL SURGERY PERFORMED ON (B)(6) 2023. THE SCREWS WERE LOOSE AND THE PROCEDURE WAS COMPLETED BY REPLACING THE LOOSE SCREWS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Hernia; Undesired Nerve Stimulation

  MAUDE report 17832038 ↗
• InjuryJul 28, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR BOTH S1 SCREWS WERE BROKEN. L5/S TLIF THERAPY. IT WAS REPORTED THAT BOTH S1 SCREWS WERE BROKEN, SO AFTER REMOVING THEM BY RE-OPERATION, A NEW TRAJECTORY WAS CREATED, AND THE SCREWS WERE REPLACED. ON (B)(6), 2022, L5/S1 TLIF WAS PERFORMED. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. PATIENT WAS UNABLE TO ACHIEVE BONE FUSION. THERE IS A POSSIBILITY OF BONE FUSION IN THE FUTURE. PATIENT HAD L5 ISOLATION SPONDYLOLISTHESIS WHEN THE SURGERY WAS PERFORMED ON (B)(6) 2022. PHYSICIAN'S OPINION THAT THE SCREW MIGHT HAVE BROKEN BECAUSE THE PATIENT'S BODY SIZE IS LARGE AND PLAYING RUGBY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17411184 ↗
• InjuryNov 16, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREW BACKED OUT. THE L4 SCREW WAS ALSO A LITTLE LOOSE. AS THE BACK PAIN WORSENED, ADDITIONAL SURGERY PERFORMED TO REMOVE THE SCREWS AND REPLACE THEM. SINCE THERE WAS A POSSIBILITY THAT THE DORSAL SIDE OF THE LEFT CAGE (CAPSTONEPEEKPTC) THAT HAD BEEN PLACED WAS INTERFERING WITH THE NERVE ROOT, THE POSTERIOR DECOMPRESSION OF THE LEFT SIDE WAS ALSO PERFORMED ADDITIONALLY SINCE THE CAGE WAS SINKING. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE ALLEGATION OF SCREW IS LOOSENESS. THERE WAS NO DEFECT WITH THE ROD.

  Patient problems: Intraoperative Pain; Pain

  MAUDE report 12818125 ↗