T2™ Spinal System 9391341Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994676467), received between Mar 7, 2017 and Mar 7, 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

Recent adverse event reports

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

• InjuryMar 7, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT WITH TUMOR IN L3 UNDERWENT POSTERIOR SPINAL FUSION AT L1-5, TOTAL END BLOCK SPONDYLECTOMY AND REPLACEMENT OF VERTEBRAL BODY AT L3 IN WHICH SPINAL INSTRUMENTATION WAS IMPLANTED. IT WAS REPORTED THAT ON UNKNOWN DATE, POST-OP, AUTOGRAFT BONE (ILIAC) AND IMPLANT BACKED OUT AND THE AUTOGRAFT BONE MOVED TO THE DIRECTION OF SPINAL CANAL AND IT GAVE A PRESSURE ON DURA MATER. DURA MATER WAS COMPRESSED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. DURING THE REVISION SURGERY, IMPLANT WAS REMOVED AND AUTOGRAFT BONE WHICH HAD ALREADY BEEN IMPLANTED IN THE PATIENT'S BODY WAS SHAVED AGAIN AND FIBULA WAS INGESTED THEN IT WAS IMPLANTED AT L3. INFECTION WAS SUSPECTED. SURGEON COMMENTED THAT " THE SIZE OF ILIAC BONE OR THE WAY ITS TRIMMING MAY HAVE CAUSED THE EVENT."

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 6383044 ↗