MESA® Spinal System 6201-36540Recalls & reported problems
VB Spine LLC · 6201-36540 · Class 2 · Implant
All models of MESA Spinal System (55)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857169173), received between Jan 15, 2021 and Aug 27, 2021 — classified as 1 injury, 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
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2021Migration; Migration
IT WAS REPORTED THAT A MESA SCREW AT L1 DISPLACED FROM A ROD POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED OR PERFORMED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12377607 ↗MalfunctionJul 13, 2021Fracture; Fracture
IT WAS REPORTED THAT THE INNER COLLET OF THREE MESA UNIPLANAR SCREWS BROKE/CHIPPED INTRA-OPERATIVELY AT T4 AND T12. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 20 MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCES RESULTED FROM THIS EVENT. THIS RECORD CAPTURES THE THIRD OF THE THREE REPORTED MESA UNIPLANAR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12159362 ↗InjuryJan 15, 2021Migration
A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO REPLACE A MESA 2 DEFORMITY UNIPLANAR SCREW WHICH DID NOT RETAIN A ROD, LEADING TO ROD MIGRATION APPROXIMATELY SIX-WEEKS AFTER IMPLANTATION POST OP THROUGH IMAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11181530 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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