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ELEVATE™ Spinal System 8880932Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 8880932 ELEVATE X-LOR 32X9MM · Class 2 · Implant

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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169430860), received between Jun 12, 2019 and Jun 12, 2019 — classified as 1 malfunction.

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

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 12, 2019Break; Break

    IT WAS REPORTED THAT INTRA-OP, THE EXPANDING SCREW SHEARED/BROKEN OFF THE POSTERIOR SIDE OF THE IMPLANT UPON ACCIDENTAL OPPOSITE TURN OF HANDLE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8690309 ↗

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Sources and updates

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