VERTE-STACK Spinal System 6246011 (UDI 00613994305374)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSERTER 6246011 HANDLE OUTER · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994305374), received between Dec 29, 2025 and Sep 20, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (4 reports).
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 Problem4
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834758 ↗MalfunctionMar 12, 2026Mechanical Problem; Product Quality Problem
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING SERVICING. IT WAS REPORTED THAT NEW SET CAME WITH INSERTERS AND INNER SHAFT WHICH DON'T THREAD IN FULLY, IT WAS NOTICED THAT BUTTON OF THE DRIVER STICKS AND IT APPEARS TIP OF INNER SHAFT IS BENT SLIGHTLY AND IT WAS NOTICED THAT EXTENDER TAB WAS BENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24577454 ↗MalfunctionMar 10, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING INSERTERS. IT WAS REPORTED THAT THERE WAS RESISTANCE TO THREADING THE INSERTER SHAFT ON THE INSIDE FOR BOTH INSERTERS, REQUIRING A LOT OF PRESSURE TO ASSEMBLE THE INSTRUMENTS. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24556028 ↗MalfunctionDec 29, 2025Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING INSERTERS USED FOR ACDF (ANTERIOR CERVICAL DISCECTOMY AND FUSION). IT WAS REPORTED THAT THE TAMPS DOWN ALLOW THE STYLET TO EASILY PASS THROUGH THEM. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23908168 ↗
Other Spinal vertebral body replacement device devices
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- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.