CD HORIZON® SOLERA® Spinal System 54850016540Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169491328), received between Feb 28, 2018 and Jul 17, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A SCREW USED ON PATIENT HAVING PERCUTANEOUS PEDICLE SCREW FIXATION OF THE LUMBAR SPINE FOR L2 VERTEBRAL BODY FRACTURE (TYPE B2), MULTIPLE TRAUMA DUE TO A TRAFFIC ACCIDENT. IT WAS REPORTED THAT, DURING SURGERY, THE MULTI AXIAL SCREW AND SET SCREW WERE USED IN ACCORDANCE WITH THE RECOMMENDED PROCEDURE, BUT THE INNER LOCKING SCREW COULD NOT BE PROPERLY ENGAGED AFTER THREE INSERTION ATTEMPTS. UPON REMOVAL, DAMAGED (STRIPPED) THREADS AT THE SCREW HEAD WERE IDENTIFIED. 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 25855291 ↗
• MalfunctionOct 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY AT L5-S1. IT WAS REPORTED THAT A BROKEN SCREW WAS DETECTED IN S1 ON THE RIGHT. THE BROKEN SCREW WAS IDENTIFIED WHILE THE IMPLANTS REMAINED IN PLACE, AND THE SPECIFIC BATCH OF THE BROKEN SCREW WAS NOT DETERMINED. THERE WERE UNKNOWN PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE ARE CURRENTLY NO PLANS TO PERFORM REVISION SURGERY TO REPLACE THE BROKEN SCREW IN S1 ON THE RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388571 ↗
• MalfunctionOct 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY AT L5-S1. IT WAS REPORTED THAT A BROKEN SCREW WAS DETECTED IN S1 ON THE RIGHT. THE BROKEN SCREW WAS IDENTIFIED WHILE THE IMPLANTS REMAINED IN PLACE, AND THE SPECIFIC BATCH OF THE BROKEN SCREW WAS NOT DETERMINED. THERE WERE UNKNOWN PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE ARE CURRENTLY NO PLANS TO PERFORM REVISION SURGERY TO REPLACE THE BROKEN SCREW IN S1 ON THE RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388569 ↗
• MalfunctionOct 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY AT L5-S1. IT WAS REPORTED THAT A BROKEN SCREW WAS DETECTED IN S1 ON THE RIGHT. THE BROKEN SCREW WAS IDENTIFIED WHILE THE IMPLANTS REMAINED IN PLACE, AND THE SPECIFIC BATCH OF THE BROKEN SCREW WAS NOT DETERMINED. THERE WERE UNKNOWN PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE ARE CURRENTLY NO PLANS TO PERFORM REVISION SURGERY TO REPLACE THE BROKEN SCREW IN S1 ON THE RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388566 ↗
• MalfunctionOct 27, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY AT L5-S1. IT WAS REPORTED THAT A BROKEN SCREW WAS DETECTED IN S1 ON THE RIGHT. THE BROKEN SCREW WAS IDENTIFIED WHILE THE IMPLANTS REMAINED IN PLACE, AND THE SPECIFIC BATCH OF THE BROKEN SCREW WAS NOT DETERMINED. THERE WERE UNKNOWN PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THERE ARE CURRENTLY NO PLANS TO PERFORM REVISION SURGERY TO REPLACE THE BROKEN SCREW IN S1 ON THE RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388565 ↗
• MalfunctionMay 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SACROILIAC AND THORACOLUMBAR THERAPY. IT WAS REPORTED THAT THE SOLERA 4.75 VOYAGER SCREW ON THE RIGHT SIDE HAS POPPED OUT OF THE PEDICLE AFTER BEING PLACED. THE SURGEON TOOK OUT THE SCREW AND DID NOT REPLACE IT.  THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RE CEIVED FROM MANUFACTURER REPRESENTATIVE THAT THERE WERE UNKNOWN PATIENT SYMPTOMS REPORTED. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE SCREW WAS NOT RETURNED BECAUSE IT WAS PLACED BACK INSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102892 ↗
• MalfunctionMay 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE SCREW WAS NOT RETURNED BECAUSE IT WAS REPOSITIONED AND PLACED BACK INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094289 ↗
• MalfunctionNov 20, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE TULIP HEAD SHEARED OFF WHILE FINAL TIGHTENING THE SCREW. SURGEON REMOVED THE BROKEN IMPLANT AND THE BROKEN PIECE, REPLACED WITH ANOTHER SCREW. PROCEDURE/TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20731792 ↗
• MalfunctionJun 3, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD FUSION L5/S1 DUE TO SCOLIOSIS. IT WAS REPORTED THAT THE DOCTOR FOUND OUT THAT THE SCREW HEADS WERE APART FROM THE SCREW BODY IN CT. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11936659 ↗
• MalfunctionJun 3, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO HAD FUSION L5/S1 DUE TO SCOLIOSIS. IT WAS REPORTED THAT THE DOCTOR FOUND OUT THAT THE SCREW HEADS WERE APART FROM THE SCREW BODY IN CT. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11927333 ↗
• InjuryFeb 28, 2018Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNSPECIFIED SURGERY. DURING SURGERY, ONE OF THE EXTENDED TABS WAS RETAINED IN THE PATIENT. THIS WAS DISCOVERED IN THE FOLLOW UP AND REVISION SURGERY HAD BEEN SCHEDULED ON (B)(6) 2018. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7302165 ↗