MESA® Spinal System 6201-35535Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857168398), received between Jul 13, 2021 and Jul 13, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 FIRST OF THE THREE REPORTED MESA UNIPLANAR SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159375 ↗
• 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 SECOND OF THE THREE REPORTED MESA UNIPLANAR SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159343 ↗