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MESA® Spinal System 801-07540Recalls & reported problems

VB Spine LLC · 801-07540 · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857136786), received between Apr 7, 2021 and Mar 9, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Migration3

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.

  • InjuryMar 9, 2022Migration; Migration

    IT WAS REPORTED THAT APPROXIMATELY TWO-MONTHS POST-OPERATIVELY THE MESA SCREWS AT RIGHT/LEFT L2 AND LEFT L3 MIGRATED. ALL THE RODS AND SCREWS WERE REMOVED AND REPLACED AND THE CONSTRUCT WAS EXTENDED. THIS REPORT CAPTURES THE SCREW AT LEFT L3.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13714721 ↗
  • InjuryApr 7, 2021Migration; Migration

    IT WAS REPORTED THAT A ROD SLIPPED OUT OF TWO MESA POLYAXIAL SCREWS POST-OPERATIVELY. FUSION WAS NOT ACHIEVED. REVISION SURGERY WAS PERFORMED WHERE BOTH SCREWS WERE EXPLANTED AND REPLACED. THIS REPORT CAPTURES THE SECOND OF THE TWO SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11628928 ↗
  • InjuryApr 7, 2021Migration; Migration

    IT WAS REPORTED THAT A ROD SLIPPED OUT OF TWO MESA POLYAXIAL SCREWS POST-OPERATIVELY. FUSION WAS NOT ACHIEVED. REVISION SURGERY WAS PERFORMED WHERE BOTH SCREWS WERE EXPLANTED AND REPLACED. THIS REPORT CAPTURES THE FIRST OF THE TWO SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11628927 ↗

Other Orthosis, spondylolisthesis spinal fixation devices

All Orthosis, spondylolisthesis spinal fixation devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.