CD HORIZON® SOLERA® Spinal System 54850017550Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169491632), received between Dec 1, 2017 and Mar 21, 2023 — classified as 6 injuries.

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.

• InjuryMar 21, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE EXTENSION OF THE VOYAGER 4.75 SCREW DID NOT BREAK OFF AT THE PREDETERMINED BREAKING POINT, BUT A LITTLE HIGHER (BROKEN), SO PART OF THE SCREW EXTENSION REMAINED IN THE PATIENT AND WAS REMOVED FROM THE PATIENT THE NEXT DAY ((B)(6) 2023) IN AN ADDITIONAL SURGERY. 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 16580336 ↗
• InjuryFeb 24, 2021Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF DEGENERATIVE DISC DISEASE, KYPHOSIS. IT WAS REPORTED THAT POST-OP, THERE WAS REPORT OF METALLOSIS FOR ALL SCREWS AND LEFT ROD WAS BROKEN. ALSO FOR SET SCREW THERE WAS LOOSENING OF SET SCREW/SCREW INTERFACE. PRODUCTS WERE EXPLANTED. PATIENT ACHIEVED SOLID FUSION. THERE WERE NO FRAGMENTS OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. EVENT DATE IS UNKNOWN, IT IS BETWEEN IMPLANT DATE AND REMOVAL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371276 ↗
• InjuryFeb 24, 2021Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF DEGENERATIVE DISC DISEASE, KYPHOSIS. IT WAS REPORTED THAT POST-OP, THERE WAS REPORT OF METALLOSIS FOR ALL SCREWS AND LEFT ROD WAS BROKEN. ALSO FOR SET SCREW THERE WAS LOOSENING OF SET SCREW/SCREW INTERFACE. PRODUCTS WERE EXPLANTED. PATIENT ACHIEVED SOLID FUSION. THERE WERE NO FRAGMENTS OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. EVENT DATE IS UNKNOWN, IT IS BETWEEN IMPLANT DATE AND REMOVAL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371262 ↗
• InjuryMar 12, 2019Break; Break

  IT WAS REPORTED THAT POST-OP, CLICKING SOUND WAS NOTED BY PATIENT. X-RAY SHOWED BROKEN S1 SCREW BILATERALLY. SCREW WAS EX-PLANTED PARTIALLY AS ITS THREAD WAS BURIED IN SACRAL SO WAS NOT REMOVED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8412613 ↗
• InjuryMar 12, 2019Break; Break

  IT WAS REPORTED THAT POST-OP, CLICKING SOUND WAS NOTED BY PATIENT. X-RAY SHOWED BROKEN S1 SCREW BILATERALLY. SCREW WAS EX-PLANTED COMPLETELY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8412611 ↗
• InjuryDec 1, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH MULTI AXIAL SCREW (MAS) SCREW. REPORTEDLY, POSTOPERATIVELY, THE SCREW HEAD POPPED OFF THE BONE SCREW, AS A RESULT THE PATIENT DEVELOPED PAIN. PATIENT UNDERWENT REVISION SURGERY FOR EXPLANT OF THE SCREW. NO FRAGMENTS OF THE IMPLANT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AFTER THE REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 7074239 ↗