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MESA Spinal System 801-90147Recalls & reported problems

VB Spine LLC · Reduction Jack MESA Rail™ Cricket® · Class 1

All models of MESA Spinal System (55)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857143708), received between Oct 18, 2019 and Jan 31, 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

Device problems

  • Fracture3

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Foreign Body In Patient1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 31, 2022Fracture; Fracture

    THIS REPORT SUMMARIZES SEVEN MALFUNCTION EVENTS WHERE THE TIPS OF MESA REDUCTION JACK CRICKETS 'MALFUNCTIONED' INTRA-OPERATIVELY. SURGERY WAS WERE SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13404903 ↗
  • MalfunctionJul 28, 2021Fracture; Fracture

    THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT WHERE THE "FEET" OF A MESA RAIL DEFORMITY REDUCTION JACK CRICKET BROKE DURING RAIL ROD INSERTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12242473 ↗
  • MalfunctionOct 18, 2019Fracture

    AFTER THE SURGEON COMPLETED THE PROCEDURE, HE NOTICED VIA X-RAY THAT THE MESA RAIL CRICKET REDUCTION JACK HE HAD USED DURING THE SURGERY LEFT FRACTURED COMPONENTS BEHIND INSIDE THE PATIENT. HE THEN IMMEDIATELY REMOVED THE FRACTURED PIECES. ADDITIONAL SURGICAL TIME OF UNDER TWO HOURS REPORTED BUT THE EXACT LENGTH OF TIME WAS NOT SPECIFIED.

    Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

    MAUDE report 9211432 ↗

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Sources and updates

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