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MESA® Small Stature Spinal System 3001-04030Recalls & reported problems

VB Spine LLC · 3001-04030 · Class 2 · Implant

All models of MESA Small Stature Spinal System (16)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888857046184), received between Mar 17, 2016 and Jan 5, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (5 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

Device problems

  • Migration5
  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • Neck Pain1
  • No Information1
  • Pain1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 5, 2022Migration; Migration

    IT WAS REPORTED THAT SLIPPAGE OF THE ROD OCCURRED ON FOUR MESA POLYAXIAL SCREWS AT L4-L5 AND L5-S1 POST-OPERATIVELY. REVISION HAS OCCURRED. THIS REPORT WILL CAPTURE THE SECOND OF FOUR SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13172575 ↗
  • InjuryJan 5, 2022Migration; Migration

    IT WAS REPORTED THAT SLIPPAGE OF THE ROD OCCURRED ON FOUR MESA POLYAXIAL SCREWS AT L4-L5 AND L5-S1 POST-OPERATIVELY. REVISION HAS OCCURRED. THIS REPORT WILL CAPTURE THE FOURTH OF FOUR SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13172555 ↗
  • InjuryJan 5, 2022Migration; Migration

    IT WAS REPORTED THAT SLIPPAGE OF THE ROD OCCURRED ON FOUR MESA POLYAXIAL SCREWS AT L4-L5 AND L5-S1 POST-OPERATIVELY. REVISION HAS OCCURRED. THIS REPORT WILL CAPTURE THE THIRD OF FOUR SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13172548 ↗
  • InjuryJan 5, 2022Migration; Migration

    IT WAS REPORTED THAT SLIPPAGE OF THE ROD OCCURRED ON FOUR MESA POLYAXIAL SCREWS AT L4-L5 AND L5-S1 POST-OPERATIVELY. REVISION HAS OCCURRED. THIS REPORT WILL CAPTURE THE FIRST OF FOUR SCREWS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13172531 ↗
  • InjuryAug 10, 2021Migration; Migration

    IT WAS REPORTED VIA CLINICAL STUDY THAT A PATIENT EXPERIENCED BACK AND NECK PAIN APPROXIMATELY 1 YEAR AFTER THEIR INDEX SURGERY. THIS WAS INITIALLY REPORTED IN RELATION TO A CASCADIA CAGE REPORTED VIA MRN 3004774118-2020-00081. ADDITIONAL INFORMATION RECEIVED ON 7/22/2021 INDICATED THERE WAS NO COMPLAINT AGAINST THIS CASCADIA CAGE AND IT WAS IN FACT TWO MESA SCREWS THAT HAD MIGRATED. IT WAS NOTED THAT A ROD HAD DISCONNECTED FROM A MESA SCREW AT RIGHT L5. THE PATIENT WAS REVISED AND IT WAS DISCOVERED AT THIS TIME THAT THE SCREW AT LEFT L6 WAS ALSO LOOSE. THE TWO PEDICLE SCREWS, AT RIGHT L5 AND LEFT L6, WERE THEN REMOVED AND REPLACED. THIS REPORT CAPTURES THE MIGRATED SCREW AT RIGHT L5.

    Patient problems: Neck Pain; Pain

    MAUDE report 12304860 ↗
  • InjuryMar 17, 2016Fracture; Fracture

    IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT A REVISION SURGERY WOULD TAKE PLACE IN WHICH A FRACTURED SCREW AND A SCREW IN WHICH A ROD SLIPPED OUT OF WOULD BE REMOVED. REVISION SURGERY TOOK PLACE (B)(6) 2016.

    Patient problems: No Information

    MAUDE report 5507923 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

Sources and updates

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