CD Horizon™ ModuLeX™ Spinal System 55904507540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000711672), received between Jun 3, 2025 and Jun 3, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 16, 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.

• InjuryJun 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING SPINAL THERAPY. PRIOR TO THE INDEX SURGERY, THERAPIES ATTEMPTED FOR THE SPINE SYMPTOMS INCLUDED ORAL MEDICATIONS, PHYSICAL THERAPY, AND STEROID INJECTIONS IT WAS REPORTED THAT DURING AN INDEX SPINAL SURGERY, THERE WAS AN INSTRUMENTATION FAILURE RELATED TO POOR BONE QUALITY AND OBESITY.  DIAGNOSTIC TESTS CONDUCTED INCLUDED AN X-RAY, WHICH SHOWED EVIDENCE OF SCREW PULLOUT, AND A COMPUTED TOMOGRAPHY SCAN, WHICH INDICATED MINIMAL LUCENCY AROUND THE TIP OF THE RIGHT S1 SCREW, SUGGESTING POSSIBLE LOOSENING. NO OBVIOUS HARDWARE FRACTURE OR ADDITIONAL PERIHARDWARE LUCENCY.  THE ADVERSE EVENT LED TO A NEW HOSPITALIZATION STARTING ON (B0(6) 2025, AND AN ADDITIONAL SPINAL SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO SCREW PULLOUT ATTRIBUTED TO POOR BONE QUALITY AND OBESITY. THE OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS RECOVERING/RESOLVING. THE INVESTIGATOR ASSESSMENT WERE PERFORMED, AND THE ADVERSE EVENT WAS ASSESSED AS NOT RELATED TO THE STUDY PROCEDURE AND STUDY DEVICE. SPONSOR ASSESSMENTS WERE PERFORMED THAT WERE DIFFERENT FROM INVESTIGATOR, AND T

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 22135087 ↗
• InjuryJun 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING SPINAL THERAPY. PRIOR TO THE INDEX SURGERY, THERAPIES ATTEMPTED FOR THE SPINE SYMPTOMS INCLUDED ORAL MEDICATIONS, PHYSICAL THERAPY, AND STEROID INJECTIONS IT WAS REPORTED THAT DURING AN INDEX SPINAL SURGERY, THERE WAS AN INSTRUMENTATION FAILURE RELATED TO POOR BONE QUALITY AND OBESITY.  DIAGNOSTIC TESTS CONDUCTED INCLUDED AN X-RAY, WHICH SHOWED EVIDENCE OF SCREW PULLOUT, AND A COMPUTED TOMOGRAPHY SCAN, WHICH INDICATED MINIMAL LUCENCY AROUND THE TIP OF THE RIGHT S1 SCREW, SUGGESTING POSSIBLE LOOSENING. NO OBVIOUS HARDWARE FRACTURE OR ADDITIONAL PERIHARDWARE LUCENCY.  THE ADVERSE EVENT LED TO A NEW HOSPITALIZATION STARTING ON (B)(6) 2025, AND AN ADDITIONAL SPINAL SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO SCREW PULLOUT ATTRIBUTED TO POOR BONE QUALITY AND OBESITY. THE OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS RECOVERING/RESOLVING. THE INVESTIGATOR ASSESSMENT WERE PERFORMED, AND THE ADVERSE EVENT WAS ASSESSED AS NOT RELATED TO THE STUDY PROCEDURE AND STUDY DEVICE. SPONSOR ASSESSMENT WERE PERFORMED THAT WERE DIFFERENT FROM INVESTIGATOR, AND TH

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 22135066 ↗