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T2™ Spinal System 9392221Recalls & reported problems

Medtronic Sofamor Danek, Inc. · CENTERPIECE 9392221 22 X 21MM 22A · 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 00613994676597), received between Jul 1, 2019 and Jul 1, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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

  • Migration or Expulsion of Device1

Patient problems

  • Pain1

Recent adverse event reports

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

  • InjuryJul 1, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED THAT THE PATIENT UNDERWENT VERTEBRAL COLUMN RESECTION AT T10-L2. BONE QUALITY OF THE PATIENT WAS REPORTED AS POOR. POST-OP, THE SCREW PLACED AT L1-L2 LOOSENED; DUE TO WHICH THE CAGE BECAME UNSTABLE AND INCLINED. THE PATIENT ALSO EXPERIENCED PAIN. HENCE, A REVISION SURGERY WAS PERFORMED AND THE LOOSENED SCREW WAS REMOVED AND REPLACED WITH A BIGGER SCREW. THE FUSION WAS ALSO EXTENDED TO L4 AND THE CAGE POSITION WAS ADJUSTED. THE PAIN DISAPPEARED AFTER THE REVISION SURGERY.

    Patient problems: Pain

    MAUDE report 8747166 ↗

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