CD Horizon™ ModuLeX™ Spinal System 559200038Recalls & reported problems
Medtronic Sofamor Danek, Inc. · RUASP/SSST 559200038 ST 5.5/6.0 RUASP/SS · 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 20763000607672), received between Jun 10, 2024 and Jun 10, 2024 — 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
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR SPINAL FUSION, PSF SEGMENTAL INSTRUMENTATION FOR SCOLIOSIS. IT WAS REPORTED THAT THE ROD SLIPPED FROM THE BOTTOM SCREW OF A SCOLIOSIS CONSTRUCT. THE SET CAP IS STILL TIGHTENED TO THE SCREW. TULIP OR SET SCREW HALFWAY OUT OF ROD. REVISION SURGERY PERFORMED ON (B)(6) 2024 AND PRODUCTS WERE REPLACED. LEVELS IMPLANTED WERE T2-L2 IN INITIAL SURGERY AND L2-L3 IN REVISION SURGERY. PATIENT HAD PAIN. NO NEUROLOGICAL COMPLICATIONS NOTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Pain
MAUDE report 19496420 ↗
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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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