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Velocity™ Expandable Interbody System 11-2644Recalls & reported problems

Spine Wave, Inc. · Expandable Implant, 22(L) X 10(W) X 8-14(H) 8 Degree Lordotic · Class 2 · Implant

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

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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10840642106909), received between Apr 24, 2017 and Oct 6, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 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

  • Migration or Expulsion of Device2
  • Positioning Problem1

Patient problems

  • Insufficient Information2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjuryOct 6, 2021Migration or Expulsion of Device

    AT APPROXIMATELY THREE MONTHS POST-OPERATIVELY, THE SURGEON PERFORMED A SURGICAL PROCEDURE TO REMOVE AN IMPLANT THAT HAD MIGRATED.

    Patient problems: Insufficient Information

    MAUDE report 12586458 ↗
  • InjurySep 21, 2021Migration or Expulsion of Device

    AT APPROXIMATELY SEVEN WEEKS POST-OPERATIVELY, THE SURGEON NOTED THAT THE IMPLANT CONSTRUCT HAD MIGRATED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE.

    Patient problems: Insufficient Information

    MAUDE report 12509959 ↗
  • InjuryApr 24, 2017Positioning Problem

    APPROXIMATELY ONE MONTH POST-OPERATIVELY, IT WAS NOTED ON RADIOGRAPHIC EXAMINATION THAT THE DEVICE HAD SHIFTED. THE SURGEON REMOVED THE DEVICE IN ONE PIECE APPROXIMATELY EIGHT MONTHS POST-OPERATIVELY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6517152 ↗

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Sources and updates

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