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VERTE-STACK® Spinal System 9193007Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 9193007 CRESCENT PEEK 30X7 · Class 2 · Implant

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 00885074520667), received between Feb 3, 2017 and Feb 3, 2017 — 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. How this data works · Data updated Oct 13, 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.

  • MalfunctionFeb 3, 2017Break; Break

    PROCEDURE: DISCECTOMY LEVELS TREATED: L2-L5 IT WAS REPORTED THAT DURING SURGERY, THE TAIL OF IMPLANT BROKE. THE SURGEON INSERTED THE PREVIOUS TWO LEVELS L4-L5 <(>&<)> L3-L4 WELL. THE LAST CAGE L2-L3 WAS IMPLANTED INTO DISTRACTED VERTEBRAL BODY BUT WHEN THE SURGEON DID THE LAST IMPACT, THE TAIL OF THE IMPLANT BROKE. THE SURGEON REMOVED THE DEBRIS OF THE CAGE FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6299488 ↗

Other SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices

All SPINAL VERTEBRAL BODY REPLACEMENT DEVICE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.