SOVEREIGN™ Spinal System 7967028Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SLEEVE 7967028 INSERTER · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994320797), received between Feb 4, 2026 and Apr 7, 2026 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE INSTRUMENTS. IT WAS REPORTED THAT DURING FIELD CONTACT, THE FOLLOWING DEVICE-RELATED ISSUES AND MALFUNCTIONS WERE IDENTIFIED: THE SLEEVE (B)(6) INSERTER WOULD NOT ATTACH WITH TRIAL, THE SHAFT 2161001 OLIF25 INTERBODY THREADED HAD A TIP THAT BROKE OFF, THE INSERTER 4360113 13MM INSERTER CASE WAS NOT ATTACHING, AND THE DRIVER 6630904 T8/T10 DRIVER WAS STRIPPED. TIP BROKE OFF FOR INSERTER 6279002 PSR ENDCAP THREADED. DRIVER 7080907 2.5 HEX SCREWDRIVER (QTY-2) WERE STRIPPED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24804111 ↗MalfunctionFeb 4, 2026Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PATIENT HAVING SPINAL THERAP Y. IT WAS REPORTED THAT THE INSERTER WAS BROKEN. 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 24256114 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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