T2™ Spinal System 9392231Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994676573), received between Dec 9, 2021 and Dec 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 9, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR THO RACIC COMPRESSION FRACTURE. IT WAS REPORTED THAT THERE WAS SCREW BACK-OUT AND RE-OPERATION FOR FUSION EXTENSION WAS PERFORMED ON (B)(6) 2021.THE T2 PLACED AT TH12 WAS SLIGHTLY SUNK INTO L1. IT WAS UNKNOWN WHETHER THIS CAUSED THE SCREW TO LOOSEN OR THE SCREW LOOSENESS CAUSED T2 TO LOOK LIKE THIS. THEY PERFORMED REPLACEMENT AT T10, REMAINED T11 AS IT WAS, PERFORMED REPLACEMENT AT L1, AND THERE WAS LOOSENESS AT L2 AND WHEN REMOVED, THE HOLE WAS WIDENED AND THE ROOT WAS VISIBLE. THEY INSERTED PEDICLE SCREW INTO TH9, L3, L4. PLACED TRANSVERSE HOOK AT TH8, PLACED OFFSET HOOK FROM BELOW AT L2 AND L4. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12966710 ↗