CD HORIZON® SOLERA® Spinal System 54850016545Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169491564), received between Jan 13, 2021 and Feb 24, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT DIAGNOSED WITH SPINAL DEGENERATION AT L4¿5 AND UNDERWENT MIS-TLIF SURGERY. IT WAS REPORTED THAT WHEN ATTEMPTING TO SECURE THE ROD, THE NUT COULD NOT BE PROPERLY LOCKED DESPITE MULTIPLE ATTEMPTS. THE SURGEON THEN REPLACED THE SCREW WITH ANOTHER SCREW OF THE SAME SIZE, AFTER WHICH THE NUT WAS SUCCESSFULLY LOCKED AND THE SURGERY WAS COMPLETED SMOOTHLY. 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 24425671 ↗
• MalfunctionNov 14, 2025Break; Fracture; Break; Fracture

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING A PATIENT HAVING VOYAGER + CRES CENT SURGERY CASE. IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE INVOLVING DECOMPRESSION AND L2-L3 DISC REPLACEMENT, FOUR VOYAGER SCREWS WERE FIXED INTO THE L2-L3 VERTEBRAL BODIES UNDER C-ARM FLUOROSCOPIC GUIDANCE. AFTER PLACEMENT OF TWO DISC CRESCENT, THE SURGICAL TEAM PROCEEDED TO INSERT SIX VOYAGER SCREWS, SIX SET SCREW, AND TWO RODS. HOWEVER, DURING THE ROD INSERTION MANEUVER, THE BREAK-OFF SECTION OF ONE VOYAGER SCREW FRACTURED. UPON INSPECTION, THE SCREW WAS DEEMED UNUSABLE AND HAD TO BE REPLACED WITH A NEW ONE. 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 23552633 ↗
• MalfunctionJul 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING PERCUTANEOUS ARTHRODESIS AND TLIF DUE TO DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT DURING IMPLANTATION OF THE VOYAGER 4.75 MAS SCREW (WITHOUT THE EXTENSIONS), THE HEAD OF THE SCREW PARTIALLY BROKE. THERE WAS NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509807 ↗
• InjuryAug 4, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH A MEDICAL HISTORY OF L5/S1 LYTIC LISTHESIS AND L4/5 DISC DEGENERATION WITH L5/S1 FORAMINAL STENOSIS. IT WAS REPORTED THAT THE PATIENTS LEFT S1 SCREW HAD BROKEN. PATIENT FELT A GRATING SENSATION. SURGEON REPORTED THAT THE PATIENT HAS SOME SYMPTOMS. PATIENT HAD PAIN SINCE SURGERY, BUT GRATING AND INCREASED PAIN. THE SCREW BROKE POST OPERATIVELY, BUT IT IS UNCERTAIN WHEN. WELL AFTER DISCHARGE. DATE OF SURGERY WAS THE (B)(6) 2021, BUT IT IS UNCERTAIN WHEN THE SCREW BROKE. PROCEDURE OR THERAPY PERFORMED WAS L4/5/S1 DECOMPRESSION AND PEDICLE SCREW FUSION. ADDITIONAL SURGERY IS PLANNED WITH NO DATE OF SURGERY AT THE MOMENT. THE PATIENT HAS THEIR BROKEN SCREW PARTS REMOVED. IT WAS DISCOVERED THAT THE ROD HAD BROKEN AND THE RIGHT S1 SCREW WAS ALSO BROKEN.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 15161843 ↗
• InjuryMar 25, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH A MEDICAL HISTORY OF L5/S1 LYTIC LISTHESIS AND L4/5 DISC DEGENERATION WITH L5/S1 FORAMINAL STENOSIS. IT WAS REPORTED THAT THE PATIENTS LEFT S1 SCREW HAD BROKEN. PATIENT FELT A GRATING SENSATION. SURGEON REPORTED THAT THE PATIENT HAS SOME SYMPTOMS. PATIENT HAD PAIN SINCE SURGERY, BUT GRATING AND PAIN WAS INCREASED. THE SCREW BROKE POST OPERATIVELY, BUT IT IS UNCERTAIN WHEN. DATE OF INITIAL SURGERY WAS THE (B)(6) 2021, BUT IT IS UNCERTAIN WHEN THE SCREW BROKE. PROCEDURE OR THERAPY PERFORMED WAS L4/5/S1 DECOMPRESSION AND PEDICLE SCREW FUSION.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 13898177 ↗
• MalfunctionMar 14, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM DISTRIBUTOR VIA HEALTHCARE PROVIDER REGARDING A PATIENT HAVING L3-L4 MIS-TLIF SURGERY DUE TO L3-4 HIVD. IT WAS REPORTED THAT, THE PATIENT UNDERWENT THE DURING THE SURGERY, THE SURGEON CONFIRMED THE COUNTER TORQUE IS FULLY SEATED. THE SURGEON INSERTED THE SET SCREW DRIVER WITH ATTACHED BREAK-OFF HANDLE. THE SURGEON CAN SPIN THE BREAK-OFF HANDLE, BUT IT FAILED TO LISTEN THE SOUND 'PIA' AND WERE BROKEN OFF SUCCESSFULLY. THE SURGEON REPLACED WITH THE ANOTHER SET SCREW, IT WAS IN THE SAME SITUATION. FINALLY, THE SURGEON UNSCREWED THE SCREW AND REPLACED WITH THE NEW SCREW BUT THE SET SCREW IS THE SAME, IT SUCCEEDED TO BE BROKEN OFF AND COMPLETE THE SURGERY. THERE WERE NO SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13754821 ↗
• MalfunctionMar 13, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA DISTRIBUTOR REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. THE PRE-OP DIAGNOSIS WAS L3-4 HIVD. IT WAS REPORTED THAT, THE PATIENT UNDERWENT THE L3-L4 MIS-TLIF SURGERY. DURING THE SURGERY, THE SURGEON CONFIRMED THE COUNTER TORQUE IS FULLY SEATED. THE SURGEON INSERTED THE SET SCREW DRIVER WITH ATTACHED BREAK-OFF HANDLE. THE SURGEON CAN SPIN THE BREAK-OFF HANDLE, BUT IT FAILED TO LISTEN THE SOUND 'PIA' AND WERE BROKEN OFF SUCCESSFULLY. THE SURGEON REPLACED WITH THE ANOTHER SET SCREW, IT WAS IN THE SAME SITUATION. FINALLY, THE SURGEON UNSCREWED THE SCREW AND REPLACED WITH THE NEW SCREW BUT THE SET SCREW IS THE SAME, IT SUCCEEDED TO BE BROKEN OFF AND COMPLETE THE SURGERY. THERE WERE NO SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13752082 ↗
• MalfunctionApr 6, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR UNKNOWN INDICATION. IT WAS REPORTED THAT WHEN  SURGEON SUCCESSFULLY PERFORMED A 2 LEVEL OLIF AT L4/5 AND L5/S1. THEN THE SURGEON PERFORM A SINGLE POSITION POSTERIOR SPINAL FUSION USING SOLERA VOYAGER 4.75 SYSTEM WITH O2-OARM + S8 NAVIGATION GUIDED FOR SCREW INSERTION. SURGEON INSERTED 6 SCREWS VERY SMOOTH USING NAVIGATION GUIDED. AND THEN INSERTED THE ROD VERY SMOOTHLY. IN THE FINAL STAGE HE INSERTED THE SET SCREWS AS WELL . HE BREAK OFF 5 SET SCREW SUCCESSFULLY. HOWEVER DURING THE LAST SET SCREW ON THE RIGHT SIDE OF THE PATIENT AT L4 LEVEL, HE COULDN'T BREAK THE SET SCREW OFF. HENCE HE KEPT ON TURNING THE SCREW DRIVER HOPING THAT THE SET SCREW CAN ENGAGE ON THE ROD AND THEN BREAK OFF. BUT IT DID NOT HAPPEN. HE TRIED IT FOR A VERY LONG TIME. AROUND 20 MINUTES STILL IT CAN NOT BREAK OFF THE FINAL SET SCREW. HENCE RIGHT SIDE BREAK OFF SET SCREW AND THE PEDICLE SCREW WAS REMOVED AND NEW PEDICLE SCREW AND NEW SET SCREW WERE USED. AND FINALLY SURGEON WAS ABLE TO LOCK THE SET SCREW IN PLACE AND PERFORM FINAL TIGHTENING AND BREAK OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617461 ↗
• MalfunctionJan 13, 2021Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR VIA MANUFACTURER REPRESENTATIVE FOR AN EVENT WHICH OCCURRED DURING THE L3-L5 MIS-TLIF SURGERY IN PATIENT DIAGNOSED WITH HIVD. IT WAS REPORTED THAT THE SURGEON SPUN THE BREAK-OFF HANDLE, BUT IT FAILED TO LISTEN THE SOUND 'PIA' AND WERE BROKEN OFF SUCCESSFULLY. THE SURGEON REPLACED WITH THE ANOTHER SET SCREW, IT WAS IN THE SAME SITUATION. THE SURGEON REPLACED WITH THE ANOTHER SET SCREW, IT WAS IN THE SAME SITUATION. THE SURGEON UNSCREWED THE SCREW AND REPLACED WITH THE NEW SCREW AND SET SCREW, IT SUCCEEDED TO BE BROKEN OFF AND COMPLETE THE SURGERY. PRODUCT WILL BE RETURNED, AND IT WAS REPLACED WITH MEDTRONIC PRODUCT. NO PATIENT INJURY / COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11162025 ↗