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T2™ Spinal System 9392225Recalls & reported problems

Medtronic Sofamor Danek, Inc. · CENTERPIECE 9392225 22 X 25MM 22B · 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 00613994676580), received between Jan 16, 2017 and Jan 16, 2017 — 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.

  • InjuryJan 16, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED THAT PATIENT WITH L4 BURST FRACTURE UNDERWENT ONE ABOVE AND ONE BELOW SURGERY AT L3-5 IN WHICH SPINAL CAGES AND SCREWS WAS IMPLANTED. POST-OP, SPACER MOVED TO THE LEFT SIDE DUE TO LOOSENING OF L3 SCREW. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN. THE PATIENT¿S BONE WAS SIGNIFICANTLY POOR. THERE IS NO PLAN TO CONDUCT REVISION SURGERY. IT WAS REPORTED THAT PATIENT HAD PAIN, BUT IT IS UNKNOWN IF THE INCISION OR LOOSENING HAS CAUSED THE PAIN.

    Patient problems: Pain

    MAUDE report 6253001 ↗

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