MESA® Spinal System 801-35530Recalls & reported problems
VB Spine LLC · Uniplanar Screw Size Ø5.5x30 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 10888857139787), 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 THIRD SCREW.
Patient problems: Pain
MAUDE report 13971582 ↗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 FOURTH SCREW.
Patient problems: Pain
MAUDE report 13971535 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 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