MESA® Spinal System 801-06550Recalls & reported problems
VB Spine LLC · 801-06550 · Class 2 · Implant
All models of MESA Spinal System (55)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857136212), received between Feb 18, 2020 and Mar 17, 2022 — classified as 1 injury, 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Migration2
- Device Dislodged or Dislocated1
Patient problems
- Injury1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2022Migration; Migration
IT WAS REPORTED THAT DURING A PLANNED REVISION SURGERY TO PROXIMALLY EXTEND THE CONSTRUCT, THE TULIP OF THE LEFT PROXIMAL SCREW AT L2 HAD PARTIALLY DISENGAGED FROM THE SCREW SHAFT POST-OPERATIVELY. SUBSEQUENTLY, THIS CAUSED A LOOSENING OF THE PROXIMAL SCREWS AND MILD SCOLIOSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13790999 ↗InjuryFeb 18, 2020Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration
IT WAS REPORTED THAT A MESA POLYAXIAL SCREW MIGRATED POST-OPERATIVELY. 'REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE SCREW.
Patient problems: Injury
MAUDE report 9720043 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
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- 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 179788635Medos International Sàrl · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM VIPER 196789300Depuy Spine, LLC · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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