CD Horizon™ ModuLeX™ Spinal System 559200028 (UDI 20763000972763)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · MAS/SS PK 559200028 STER 5.5/6.0 CCM 2PK · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20763000972763), received between Jun 3, 2025 and Jun 3, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 1 most recent of 1 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 PERI HARDWARE 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 ASSESSMENTS WERE PERFORMED THAT WERE DIFFERENT FROM INVESTIGATOR, AND TH
Patient problems: Osteopenia/ Osteoporosis
MAUDE report 22135583 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.