MESA® Spinal System 801-35540Recalls & reported problems
VB Spine LLC · Uniplanar Screw Size Ø5.5x40 mm · 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 10888857139862), received between Mar 31, 2022 and Mar 31, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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.
Most reported problems
Device problems
- Migration2
Patient problems
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2022Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST-OPERATIVELY, THE PATIENT WAS EXPERIENCING SIGNIFICANT PAIN. SUBSEQUENTLY, IT WAS DISCOVERED 4 MESA UNIPLANAR SCREWS HAD LOOSENED. REVISION SURGERY HAS NOT BEEN PERFORMED AT THIS TIME. THIS REPORT CAPTURES THE SECOND SCREW.
Patient problems: Pain
MAUDE report 13971855 ↗InjuryMar 31, 2022Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY 1 MONTH POST-OPERATIVELY, THE PATIENT WAS EXPERIENCING SIGNIFICANT PAIN. SUBSEQUENTLY, IT WAS DISCOVERED 4 MESA UNIPLANAR SCREWS HAD LOOSENED. REVISION SURGERY HAS NOT BEEN PERFORMED AT THIS TIME. THIS REPORT CAPTURES THE FIRST SCREW.
Patient problems: Pain
MAUDE report 13971246 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
- CD HORIZON® Spinal System 5540030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis230 reports
- CD HORIZON® Spinal System 7578302Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis122 reports
- EXPEDIUM 179762480Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis114 reports
- ReLine 13550000Nuvasive, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis55 reports
- CD HORIZON® Spinal System 5440030Medtronic Sofamor Danek, Inc. · Pedicle screw spinal system, adolescent idiopathic scoliosis50 reports
- EXPEDIUM 179712640Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis28 reports
- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM 179788635Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis18 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.
How reports and recalls are matched · Editorial policy · Report an error on this page