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T2™ Spinal System 9402215Recalls & reported problems

Medtronic Sofamor Danek, Inc. · END CAP 9402215 22MM 15 DEGREE · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994676320), received between Mar 21, 2018 and Mar 21, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1

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.

  • InjuryMar 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PATIENT UNDERWENT CORPECTOMY PROCEDURE DUE TO INFECTION AT L4-L5. POST-OP, ONE OF THE IMPLANTED ENCAPS BECAME DISLODGED FROM THE CENTRAL BODY AND CAUSED THE CAGE TO SHIFT WHICH WAS IDENTIFIED DURING A LOCALIZED X-RAY SCAN. IT WAS FOUND THAT THE ENCAP ON THE BOTTOM HAD DETACHED WHICH CAUSED THE CAGE TO SHIFT ANTERIORLY BECOMING LODGED IN THE DETACHED ENCAP. PATIENT WAS UNDERWENT A REVISION SURGERY FOR THE REPLACEMENT OF THE IMPLANTS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7356593 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.