CD HORIZON® SOLERA® Spinal System 55720005550Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169761612), received between Dec 30, 2025 and Dec 30, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Loosening 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 PRODUCT USED FOR SPINAL FUSION THERAPY IN A PATIENT WITH CLINICAL ID (B)(6), STUDY NAME AILLIANCE MDT22045CSTAIL. IT WAS REPORTED THAT AT THE 12-MONTH FOLLOW-UP VISIT, IT WAS NOTED THAT THE SUBJECT HAD NOT FULLY FUSED AT ALL TREATED LEVELS AND ALL THE IMPLANTED DEVICES DID NOT APPEAR STABLE AND SECURE. THERE WERE NO FURTHER PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THERE IS NO ASSESSMENTS MADE BY SPONSOR, INVESTIGATOR AND CEC REGARDING THE RELATEDNESS FOR PRODUCT/THERAPY/PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT PATIENT IS DOING WELL OVERALL, AND CERTAINLY MUCH BETTER THAN PRE-OP, AND IS QUITE SATISFIED WITH HIS CURRENT STATE. THERE IS NO NEED TO GO THROUGH ANOTHER MAJOR SURGERY, DESPITE THE CT SHOWING PSEUDARTHROSIS (NONUNION) AT THE UPPERMOST FUSION LEVEL L1-2. AS THE L1 SCREWS ARE GROSSLY LOOSENED, THE LIKELIHOOD OF THAT SEGMENT GOING ON TO SOLID UNION IS VERY LOW. AS SUCH, SURGEON DO NOT THINK THAT BONE STIMULATOR IS LIKELY TO BE OF BENEFIT AND EXPLAINED THAT IT IS ESSENTIALLY RIGHT NOW FUNCTIONING

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23919816 ↗