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ENDOSKELETON® TAS 2300-6525Recalls & reported problems

Medtronic Sofamor Danek, Inc. · Bone Screw, 6.5mm x 25mm · Class 2 · Implant

Data updated Oct 18, 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 00191375001867), received between Feb 22, 2018 and Feb 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

Most reported problems

Device problems

  • Material Deformation1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 22, 2018Material Deformation; Material Deformation

    IT WAS REPORTED THAT, DURING A TAS IMPLANT LEVEL 1 (L4/5) PROCEDURE, WHILE INSERTING THE SECOND SCREW THE SURGEON NOTICED THE THREAD WAS DELAMINATING FROM THE SCREW. THE SURGEON REMOVED THE ENTIRE SCREW AS WELL AS THE DELAMINATED THREAD FROM THE PATIENT. THE PROCEDURE WAS STILL ABLE TO BE COMPLETED ON THE PATIENT WITHOUT DELAY. AT THE TIME OF REPORTING THERE WERE NO REPORTED OR KNOWN ADVERSE EFFECTS TO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7289855 ↗

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Sources and updates

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