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ELEVATE™ Spinal System 8657008Recalls & reported problems

Medtronic Sofamor Danek, Inc. · DISTRACTOR 4 8657008 ELEVATE · Class 2

All models of ELEVATE Spinal System (33)

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169432246), received between Jul 3, 2017 and Jul 3, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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

  • Break1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 3, 2017Break; Break

    IT WAS REPORTED THAT INTRA-OP, A LARGE PART OF THE DISTRACTOR TRIAL BROKE OFF IN THE DISC SPACE OF PATIENT'S BODY AND COULD NOT BE RETRIEVED.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 6683789 ↗

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Sources and updates

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