CD HORIZON® SOLERA® Spinal System 641003050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169490802), received between May 23, 2020 and Aug 4, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH A MEDICAL HISTORY OF L5/S1 LYTIC LISTHESIS AND L4/5 DISC DEGENERATION WITH L5/S1 FORAMINAL STENOSIS. IT WAS REPORTED THAT THE PATIENTS LEFT S1 SCREW HAD BROKEN. PATIENT FELT A GRATING SENSATION. SURGEON REPORTED THAT THE PATIENT HAS SOME SYMPTOMS. PATIENT HAD PAIN SINCE SURGERY, BUT GRATING AND INCREASED PAIN. THE SCREW BROKE POST OPERATIVELY, BUT IT IS UNCERTAIN WHEN. WELL AFTER DISCHARGE. DATE OF SURGERY WAS THE (B)(6) 2021, BUT IT IS UNCERTAIN WHEN THE SCREW BROKE. PROCEDURE OR THERAPY PERFORMED WAS L4/5/S1 DECOMPRESSION AND PEDICLE SCREW FUSION. ADDITIONAL SURGERY IS PLANNED WITH NO DATE OF SURGERY AT THE MOMENT. THE PATIENT HAS HAD THEIR BROKEN SCREW PARTS REMOVED. IT WAS DISCOVERED THAT THE ROD HAD BROKEN AND THE RIGHT S1 SCREW WAS ALSO BROKEN.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 15161853 ↗
• InjuryMay 23, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. IT WAS REPORTED THAT ANTEROPOSTERIOR AND LATERAL X-RAY TAKING LUMBAR FUSION PROVIDED. AN INTERESTING CONSTRUCT WITH AN OBLIQUE ARCUTATION OF THE BILATERAL RODS ARE PRESENT. THERE AT LEAST ONE PARTIAL SCREW SHRINK CONTAINED IN THE SUPERVALU VERTEBRAL BODY CONSISTENT WITH THE PROVIDED HISTORY OF FRACTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10084483 ↗