EIT TLIF Trial TFT81030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260557775202), received between Jul 21, 2022 and Jul 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K170503); they may or may not involve this specific model.

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.

• MalfunctionJul 21, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THE SURGEON WAS TRIALING EIT CONDUIT CAGE WITH THE APPROPRIATE TRIAL INSERTER (TFT20101) WITH A 10MM (TFT81030) TRIAL. UPON TIGHTENING THE TRAIL AS PER THE SURGICAL TECHNIQUE, THE INNER SHAFT OF THE TRIAL SHEARED, LEAVING THE TRIAL AND THE BROKEN INSERT INSIDE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) TRIAL H 10MM 8DEG 32/10. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075690 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170503. One submission often covers many models, so check the product and lot details in each record.

• Z-1324-2022 · May 20, 2022 · Open, Classified
  EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD
• Z-1323-2022 · May 20, 2022 · Open, Classified
  EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD