MESA® Spinal System 6201-08570Recalls & reported problems
VB Spine LLC · 6201-08570 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857165793), received between May 29, 2020 and May 29, 2020 — 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 Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2020Migration; Migration
IT WAS REPORTED THAT TWO MESA 2 POLYAXIAL SCREWS MIGRATED POST-OPERATIVELY. THE PATIENT CAME IN FOR A POST OP VISIT AND IMAGES SHOWED RODS HAD DISENGAGED FROM SCREWS AT PELVIC LEVEL BILATERALLY. FUSION HAS BEEN ACHIEVED. IT IS UNKNOWN IF REVISION SURGERY HAS BEEN SCHEDULED. THIS REPORT REPRESENTS THE FIRST OF THE TWO SCREWS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10102774 ↗MalfunctionMay 29, 2020Migration; Migration
IT WAS REPORTED THAT TWO MESA 2 POLYAXIAL SCREWS MIGRATED POST-OPERATIVELY. THE PATIENT CAME IN FOR A POST OP VISIT AND IMAGES SHOWED RODS HAD DISENGAGED FROM SCREWS AT PELVIC LEVEL BILATERALLY. FUSION HAS BEEN ACHIEVED. IT IS UNKNOWN IF REVISION SURGERY HAS BEEN SCHEDULED. THIS REPORT REPRESENTS THE SECOND OF THE TWO SCREWS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10102552 ↗
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
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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