CD HORIZON® SOLERA® Spinal System 54850017540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169491656), received between Feb 12, 2020 and Feb 24, 2021 — classified as 2 injuries, 1 malfunction.

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

• 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 11371310 ↗
• 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 11371309 ↗
• MalfunctionFeb 12, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS SECOND REVISION SURGERY. INTRA-OPERATIVELY, THE SCREW WAS BROKEN DIRECTLY UNDER THE TULIP AND IT WAS NOT SEEN IN THE PRIOR CT SCAN. THUS, THE SCREW WAS TAKEN OUT AND A NEW SCREW WAS PLACED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9697670 ↗