MESA® Spinal System 801-06540Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888857136113), received between Apr 15, 2020 and Mar 9, 2022 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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

Recent adverse event reports

The 6 most recent of 6 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 RIGHT L2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13714787 ↗
• InjuryJun 4, 2020Migration; Migration

  IT WAS REPORTED THAT A MESA POLYAXIAL SCREW IN S1 MIGRATED POST-OPERATIVELY. WHILE REPOSITIONING A SCREW AT L5, THE SURGEON NOTICED THAT THE CORRESPONDING ROD WAS COMPLETELY LOOSE FROM THE SCREW THAT WAS IMPLANTED IN S1. THE ROD WAS ONLY BEING HELD BY THE SCREW AT L5. THE S1 SCREW WAS REMOVED AND REPLACED WITH A NEW SCREW. THIS REPORT REPRESENTS THE S1 SCREW.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10121092 ↗
• InjuryApr 21, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO MESA POLYAXIAL SCREWS FRACTURED POST-OPERATIVELY. REVISION WAS PERFORMED ALONG WITH AN EXTENSION. THE SHAFTS OF BOTH SCREWS REMAIN IN THE PATIENT AS THEY COULD NOT BE REMOVED. THE SURGERY WAS COMPLETED WITH A 30 MINUTE SURGICAL DELAY. THIS REPORT REPRESENTS THE SECOND OF TWO SCREWS.

  Patient problems: Injury

  MAUDE report 9983220 ↗
• InjuryApr 21, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO MESA POLYAXIAL SCREWS FRACTURED POST-OPERATIVELY. REVISION WAS PERFORMED ALONG WITH AN EXTENSION. THE SHAFTS OF BOTH SCREWS REMAIN IN THE PATIENT AS THEY COULD NOT BE REMOVED. THE SURGERY WAS COMPLETED WITH A 30 MINUTE SURGICAL DELAY. THIS REPORT REPRESENTS THE FIRST OF TWO SCREWS.

  Patient problems: Injury

  MAUDE report 9983218 ↗
• MalfunctionApr 15, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO MESA POLYAXIAL SCREWS FRACTURED POST-OPERATIVELY. THE PATIENT PRESENTED WITH LOWER BACK PAIN. REVISION SURGERY WILL NOT BE PERFORMED. THIS REPORT REPRESENTS THE SECOND OF THE TWO SCREWS.

  Patient problems: Pain

  MAUDE report 9962935 ↗
• MalfunctionApr 15, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO MESA POLYAXIAL SCREWS FRACTURED POST-OPERATIVELY. THE PATIENT PRESENTED WITH LOWER BACK PAIN. REVISION SURGERY WILL NOT BE PERFORMED. THIS REPORT REPRESENTS THE FIRST OF THE TWO SCREWS.

  Patient problems: Pain

  MAUDE report 9962934 ↗