N/A 9296000Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSTRUMENT 9296000 INSERTER · Class 2
- 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 00613994121035), received between Apr 6, 2026 and Apr 6, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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.
Reports received per month
Most reported problems
Device problems
- 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.
MalfunctionApr 6, 2026Mechanical Problem
INFORMATION RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSERTER USED FOR TLIF(TRANSFO RAMINAL LUMBAR INTERBODY FUSION). IT WAS REPORTED THAT THE PHYSICIAN CANNOT HOLD THE INSERTER IN PLACE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787582 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.