SOVEREIGN™ Spinal System 7967079Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SHAFT 7967079 S INSERTER · Class 2
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 00613994545305), received between Dec 4, 2025 and Dec 4, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionDec 4, 2025Break; Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPO RTED THAT INSTRUMENT BREAKAGE OCCURRED WITH THE INSERTER DURING SPINAL SURGERY. THE PRODUCT WAS UTILIZED CORRECTLY ACCORDING TO THE INSTRUCTIONS FOR USE. NO FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE SOVEREIGN INNER SHAFT BROKE DURING INSERTION OF A SMALL SOVEREIGN IMPLANT. THE INNER SHAFT BROKE NEAR THE HANDLE ON THE THIRD OR FOURTH TIME IT WAS STRUCK WITH A MALLET. THIS PARTICULAR INSERTER HAS BEEN USED FOR MANY CASES. THE IMPLANT WASN¿T QUITE IN FINAL POSITIONING YET. WE USE THE POSITION ADJUSTER OR SECONDARY IMPACTOR TO PLACE THE IMPLANT IN PERFECT POSITION. THE PATIENT WAS UNHARMED. THE CASE WENT VERY WELL OTHER THAN THE INSERTER BREAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23713973 ↗
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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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