MESA Spinal System 6201-90084Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888857320468), received between Oct 30, 2020 and Sep 10, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Fracture

  A company representative reported that the tip of a Mesa Jack Cricket fractured intra-operatively and that the fractured tip remains in the patient. The procedure was completed successfully with a 10 minute surgical delay and no adverse consequence to the patient. On (b)(6) 2026, an additional fractured Mesa Cricket was returned and the fractured tip may have also remained in the patient. This report captures the second returned Mesa Cricket.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716455 ↗
• MalfunctionJun 29, 2026Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A MESA JACK CRICKET FRACTURED INTRA-OPERATIVELY AND THAT THE FRACTURED TIP REMAINS IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659921 ↗
• MalfunctionJul 29, 2022Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF Q2 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES TWO INSTANCES OF INTRAOPERATIVE MESA 2 REDUCTION JACK TIP FRACTURE. IN BOTH INSTANCES, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. IN ONE (OF TWO) INSTANCES, THERE WAS A TEN-MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135588 ↗
• MalfunctionApr 29, 2022Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF Q1 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES TWO INSTANCES OF INTRAOPERATIVE MESA 2 REDUCTION JACK TIP FRACTURE. IN BOTH CASES, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251953 ↗
• MalfunctionJan 26, 2022Fracture; Mechanical Jam; Fracture; Mechanical Jam

  THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS WHERE THE FEET OF MESA 2 REDUCTION JACK CRICKETS FRACTURED INTRA-OPERATIVELY. SURGERIES WERE SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13361956 ↗
• MalfunctionOct 28, 2021Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE THE TIP OF AN MESA 2 REDUCTION JACK CRICKET BROKE INTRA-OPERATIVELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TWO MINUTE SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12714606 ↗
• MalfunctionJul 29, 2021Fracture; Fracture

  THIS REPORT SUMMARIZES FOUR MALFUNCTION EVENTS WHERE THE TIPS OF MESA 2 REDUCTION JACK CRICKETS BROKE INTRA-OPERATIVELY. THE PROCEDURES WERE SUCCESSFULLY COMPLETED WITH NO DELAY OR ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12248605 ↗
• MalfunctionApr 29, 2021Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE THE 'FOOT" OF A MESA DEFORMITY REDUCTION JACK CRICKET BROKE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11745675 ↗
• InjuryOct 30, 2020Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE TIP OF A MESA 2 REDUCTION JACK CRICKET FRACTURED INTRA-OPERATIVELY. IT WAS LATER NOTED THAT THE FRACTURED COMPONENT HAD BEEN LEFT INSIDE THE PATIENT AND REVISION SURGERY TO REMOVE THE TIP HAS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10766496 ↗