CD Horizon™ ModuLeX™ Spinal System G55900206540Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SHANK G55900206540 6.5 X 40 ATS STERILE · 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 00763000435356), received between Mar 12, 2026 and Mar 12, 2026 — 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
- Mechanical Jam1
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 12, 2026Mechanical Jam; Loosening of Implant Not Related to Bone-Ingrowth
INFORMATION FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT DURING A REOPERATION FOR LOOSENING OF TWO SCREWS IMPLANTED AT L2/3 IN A POSTEROLATERAL LUMBAR FUSION PROCEDURE, THE REMOVED DEVICE WAS FOUND TO HAVE AN ADHERED SCREW HEAD AND SCREW THREAD RESULTING IN RESTRICTED MOTION, WITH MINIMAL MOVEMENT ACHIEVED ONLY WHEN FORCE WAS APPLIED, NO MALFUNCTION OF THE SET SCREW, NO PATIENT SYMPTOMS, AND NO FURTHER COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24577306 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.