MESA® Small Stature Spinal System 3001-35530Recalls & reported problems
VB Spine LLC · 3001-35530 · Class 2 · Implant
All models of MESA Small Stature Spinal System (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857049864), received between Aug 24, 2021 and Aug 24, 2021 — classified as 2 malfunctions.
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
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2021Migration; Migration
IT WAS REPORTED THAT MESA RAIL RODS SLIPPED FROM MESA UNIPLANAR SCREWS AT T3 POST-OPERATIVELY. PLANS FOR REVISION SURGERY ARE NOT KNOWN AT THIS TIME. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS RECORD CAPTURES THE SECOND OF THE TWO MESA UNIPLANAR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12360360 ↗MalfunctionAug 24, 2021Migration; Migration
IT WAS REPORTED THAT MESA RAIL RODS SLIPPED FROM MESA UNIPLANAR SCREWS AT T3 POST-OPERATIVELY. PLANS FOR REVISION SURGERY ARE NOT KNOWN AT THIS TIME. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS RECORD CAPTURES THE FIRST OF THE TWO MESA UNIPLANAR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12360354 ↗
Other Pedicle screw spinal system, adolescent idiopathic scoliosis devices
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- 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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