CD HORIZON® SOLERA® Spinal System 651003070Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169748040), received between Sep 28, 2021 and Sep 28, 2021 — classified as 1 injury.

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.

• InjurySep 28, 2021Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THERE IS POSSIBLE INFECTION. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE HEAD OF SCREW WAS MOBILE AND SET SCREW LOOSE. THE PEDICLE SCREW WAS SOLID WITHIN THE PEDICLE AND THE ROD HAD AN INDENTATION SIGNIFYING PROPER FINAL TIGHTENING. FAILURE BETWEEN HEAD OF SCREW, ROD AND SET SCREW CAUSING LOOSENING AND A METALLOSIS EFFECT. THE LOT NUMBERS OF PRODUCT ID: 5540030 IS H5453997, PRODUCT ID: 55840007550 IS H59226 AND PRODUCT ID: 651003070 IS 0587500W. INFECTION CAUSE IS UNKNOWN. HOWEVER, METALLOSIS WAS A CAUSE FOR CONCERN. EXACT DATE OF IMPLANTATION IS UNKNOWN. STATED TO BE ROUGHLY 2 ¿ 2 ½ YEARS AGO.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Post Operative Wound Infection

  MAUDE report 12538872 ↗