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PEEK PREVAIL™ Cervical Interbody Device 4210764Recalls & reported problems

Medtronic Sofamor Danek, Inc. · IMPLANT 4210764 STANDALONE 16 X 14 X 7MM · Class 2 · Implant

All models of PEEK PREVAIL Cervical Interbody Device (3)

Data updated Oct 18, 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 00613994502100), received between Apr 22, 2019 and Apr 22, 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 18, 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.

  • MalfunctionApr 22, 2019Break; Break

    PRE-OPERATIVE DIAGNOSIS: BILATERAL RADICULOPATHY DUE TO DISC AT C5-6-7 LEVEL PROCEDURE: ACDF(ANTERIOR CERVICAL DISCECTOMY AND FUSION) IT WAS REPORTED THAT, INTRA-OP, IT WAS OBSERVED THAT FLANGES WERE MOVING DURING SCREW INSERTION. THE IMPLANT BROKE INTO TWO PIECES. THE BROKEN DEVICE WAS EXPLANTED. THE IMPLANT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT WERE UNKNOWN.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8535186 ↗

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Sources and updates

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