MESA® Small Stature Spinal System 3001-04540Recalls & reported problems
VB Spine LLC · 3001-04540 · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857046320), received between Jul 22, 2019 and Jul 22, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Migration2
Patient problems
- Injury2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2019Migration; Detachment of Device or Device Component; Migration
IT WAS REPORTED THAT A MESA SMALL STATURE DEFORMITY POLYAXIAL SCREW, IMPLANTED IN L1, DISENGAGED POST-OPERATIVELY. DURING REVISION SURGERY, SURGEON NOTED THE LOCKING MECHANISM OF THE SCREW WAS OPENED. THIS RECORD REPRESENTS 1 OF 2 SCREWS.
Patient problems: Injury
MAUDE report 8813644 ↗InjuryJul 22, 2019Migration; Detachment of Device or Device Component; Migration
IT WAS REPORTED THAT A MESA SMALL STATURE DEFORMITY POLYAXIAL SCREW, IMPLANTED IN L1, DISENGAGED POST-OPERATIVELY. DURING REVISION SURGERY, SURGEON NOTED THE LOCKING MECHANISM OF THE SCREW WAS OPENED. THIS RECORD REPRESENTS 2 OF 2 SCREWS.
Patient problems: Injury
MAUDE report 8813643 ↗
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- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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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