MESA® Spinal System 6201-04040Recalls & reported problems
VB Spine LLC · 6201-04040 · Class 2 · Implant
All models of MESA Spinal System (55)
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 10888857162815), received between Apr 15, 2025 and Apr 15, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
Patient problems
- Discomfort2
- Insufficient Information2
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 15, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 1 YEAR AND 10 MONTHS POST-OPERATIVELY TO ADDRESS TWO FRACTURED MESA POLYAXIAL SCREWS. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.
Patient problems: Discomfort; Insufficient Information; Pain
MAUDE report 21838702 ↗InjuryApr 15, 2025Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 1 YEAR AND 10 MONTHS POST-OPERATIVELY TO ADDRESS TWO FRACTURED MESA POLYAXIAL SCREWS. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.
Patient problems: Discomfort; Insufficient Information; Pain
MAUDE report 21838684 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- 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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