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MESA® Spinal System 801-07545Recalls & reported problems

VB Spine LLC · 801-07545 · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888857136830), received between Jun 5, 2020 and Jun 5, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

  • Insufficient Device Problem Information1
  • Migration1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 5, 2020Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

    DURING A PLANNED REVISION SURGERY TO PERFORM ADDITIONAL COMPRESSION ON AN EXISTING CONSTRUCT, THE SURGEON NOTED THAT A MESA POLYAXIAL SCREW WAS NOT SECURED TO THE ROD. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10125054 ↗

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