CD Horizon™ ModuLeX™ Spinal System 55900105545Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SHANK 55900105545 5.5 X 45 CORTICAL · 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
- 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 00763000435523), received between Aug 6, 2024 and Aug 6, 2024 — classified as 1 injury.
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
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.
InjuryAug 6, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SHANK HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY FOR LUMBAR RADICULOPATHY AND SPONDYLOLISTHESIS. IT WAS REPORTED THAT PATIENT UNDERWENT AN L5-S1 MIS TLIF WITH MODULEX CORTICAL SCREWS, AND CATALYFT PL. DR PLACED CORTICAL TRAJECTORY SCREWS USING INTRAOPERATIVE IMAGING FOLLOWED BY S8 STEALTH NAVIGATION AND THEN PROCEEDED WITH A DIRECT DECOMPRESSION OF THE NURAL ELEMENTS FOLLOWED BY INSERTION OF AN INTERBODY DEVICE AT 5-1. PATIENT FOLLOWED UP ON (B)(6) 2024 WITH COMPLAINTS OF BACK PAIN AND A RETURN OF LEFT LEG PAIN. NORMAL BONE DENSITY WAS REPORTED. UPON IMAGING, IT WAS REVEALED THAT BILATERAL S1 SCREW SHANKS WERE FRACTURED. PATIENT DID UNDERGO A REVISION SURGERY WHICH INCLUDED AN ANTERIOR APPROACH, REMOVAL OF THE TLIF CAGE AND SUBSEQUENT INSERTION OF AN ALIF CAGE AND PLATE. THE CATALYFT CAGE WAS DISPOSED AT THE TIME OF REMOVAL. THE FRACTURED SCREWS REMAIN IN THE PATIENT AND POSTERIOR SCREWS MAY BE REMOVED AT A FUTURE DATE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Pain
MAUDE report 19918979 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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