CD Horizon™ ModuLeX™ Spinal System 559200034 (UDI 20763000607634)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · RMAS/SS PK 559200034 STER 5.5/6.0 2PK · Class 2 · Implant
All models of CD Horizon ModuLeX Spinal System (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20763000607634), received between Jan 4, 2026 and Feb 20, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Dislodged or Dislocated1
Patient problems
- Foreign Body In Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2026Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL REGARDING A PATIENT HAVING WHO HAD SPINAL THERAPY (T2-L5) DUE TO ADOLESCENT IDIOPATHIC SCOLIOSIS. IT WAS REPORTED THAT BOTH L5 SET CAPS DISSEMBLED / BACKED OUT FROM SCREW HEADS. PATIENT REPORTED PAIN AND REVISION SURGERY WAS PERFORMED TO EXPLANT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Pain
MAUDE report 24398755 ↗InjuryJan 4, 2026Break
INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT AFTER THE CASE THAT ONE HEAD HAD POPPED OFF OF THE SHANK. PRODUCT EXPLANT COMPLETED ON (B)(6) 2025. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT, THE HEAD POPPED OFF THE SHANK AFTER BEING ATTACHED AND AFTER THE ROD HAD BEEN FINAL TIGHTENED INTO THE HEAD WITH THE SET SCREW. THEY WERE A CONTRIBUTING FACTOR BUT NOT THE MAIN REASON FOR REVISION SURGERY. MAIN REASON WAS BECAUSE SEVERAL OF THE OLD NU VASIVE SET SCREWS POPPED OFF THE SCREWS POST OP.
Patient problems: Foreign Body In Patient
MAUDE report 23954395 ↗
Other Appliance, fixation, spinal intervertebral body devices
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- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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