MESA Spinal System 801-90066Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857143272), received between Oct 29, 2021 and Apr 29, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 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 14253957 ↗
• MalfunctionJan 26, 2022Fracture; Fracture

  THIS REPORT SUMMARIZES TWO MALFUNCTION EVENTS WHERE THE TIPS OF MESA DEFORMITY REDUCTION JACK CRICKETS "BROKE" 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 13361620 ↗
• MalfunctionOct 29, 2021Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE THE TIP OF A MESA REDUCTION JACK CRICKET FRACTURED INTRA-OPERATIVELY. ALL DEBRIS WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY OR ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12722645 ↗