T-PAL 03.812.512Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034727981), received between Mar 11, 2021 and Mar 11, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Compatibility Problem” (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 18, 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.

• MalfunctionMar 11, 2021Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE T-PAL IMPLANT KINKED WHEN IT WAS KNOCKED INTO THE DISC SPACE FROM AN UNKNOWN T-PAL INSERTER. BECAUSE OF A DURAL LEAKAGE AND SCARRING FROM A FORMER OPERATION, THE USER HAS GIVEN A SLIGHTLY LATERAL ANGLE. IT WAS REPORTED THAT THE PATIENT ALSO HAD HARD BONES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER T-PAL INSERTER. ONE (1) T-PAL TRIAL SPACER AND ONE (1) APPLICATOR INNER SHAFT WERE ALSO UNABLE TO ASSEMBLE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN IMPLANT INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER 12MM X 32MM 12MM HEIGHT. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11462407 ↗