CD Horizon™ ModuLeX™ Spinal System G55900207540Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SHANK G55900207540 7.5 X 40 ATS STERILE · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00763000435400), received between Mar 4, 2025 and Mar 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY FOR LUMBAR SPINAL STENOSIS. LEVELS IMPLANTED WAS L4/5. IT WAS REPORTED THAT TWO SCREWS ON THE RIGHT SIDE HAD BECOME DISLODGED. REVISION SURGERY HAS BEEN SCHEDULED FOR THE REMOVAL OF SCREWS. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED SCREWS WERE EXPLANTED ON (B)(6) 2025 AND RETURNED TO PATIENT. THEY WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 WITH NO PATIENT COMPLICATIONS. THE PRODUCTS WERE DISCARDED BY CUSTOMER AND WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21515801 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- Elegance® Anterior Cervical Plate 53430114Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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