CD Horizon™ ModuLeX™ Spinal System 55904506545Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000711610), received between Jun 3, 2025 and Jun 10, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Loosening of Implant Not Related to Bone-Ingrowth

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL PATIENT ID (B)(6), STUDY ID MDT22045CSTAIL / MDT22045CSTAIL, SUB EVENT 03. IT WAS REPORTED THAT, PATIENT WITH POST JUNCTIONAL KYPHOSIS WITH SEVERE COMPRESSION OF L2 AND CUT OUT OF SCREWS. SCHEDULED FOR REVISION T11-L3 FUSION. DESCRIPTION: POST-JUNCTIONAL KYPHOSIS. SITE RELATED ASSESSMENT: ADVERSE EVENT WAS PROBABLY RELATED TO STUDY DEVICE AND PROCEDURE. TOTAL ESTIMATED BLOOD LOSS WAS 150ML. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. 2026-FEB-04 LSH 1474990585 (REP, SDY): ADDITIONAL INFORMATION RECEIVED STATING ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2025 AND THE SCREWS WERE EXPLANTED. ADDITIONAL INFORMATION RECEIVED STATING PATIENT WAS HOSPITALIZED (B)(6) 2026. ADDITIONAL MEDICATION WAS ADMINISTERED AND SPINAL SURGERY WAS PERFORMED ON (B)(6) 2026. MEDICATIONS ARE AS FOLLOWS - FENTANYL 50UG DUE TO ADDITIONAL LUMBAR SURGERY (ANESTHESIA). STARTED ON (B)(6) 2026, ENDED ON (B)(6) 2026. HYDROMORPHONE 0.5MG DUE TO PAIN POST-LUMBAR SPINE SURGERY. STARTED ON (B)(6) 2026, ENDED ON (B)(6) 2026. HYDROMORPHONE 0.25MG DUE TO

  Patient problems: Stenosis

  MAUDE report 25455004 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  CAUSAL RELATIONSHIP ONLY TO CD HORIZON MODULEX AND NO MALFUNCTION WITH THE OTHER SCREWS.

  Patient problems: Back pain

  MAUDE report 24289780 ↗
• 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 THE

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 22134898 ↗
• 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 THE

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 22134841 ↗