N/A 3032028Recalls & reported problems
Medtronic Sofamor Danek, Inc. · DTS 3032028 ZEVO DISTAL 28 DEGREE · Class 1
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 00643169342385), received between Jul 14, 2025 and Jul 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Align” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Align1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2025Mechanical Problem; Failure to Align; Mechanical Problem; Failure to Align
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C4/5/6 OSSIFICA TION OF ANTERIOR LONGITUDINAL LIGAMENT AND CERVICAL ANTERIOR FUSION. IT WAS REPORTED THAT WHEN ATTEMPTING TO GRASP THE ZEVO PLATE USING THE DTS GUIDE, IT COULD NOT BE SECURELY HELD, AND THE LOOSENESS WAS SIGNIFICANT. THE PROTRUSION OF THE DTS GUIDE DID NOT FIT INTO THE SLOT LOCATED ON THE SIDE OF THE PLATE. THE SAME ISSUE OCCURRED EVEN WHEN USING THEZV DTS ADJUSTABLE CLAMP. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22491411 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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