T-PAL 03.812.309Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034727844), received between Jul 7, 2022 and Sep 30, 2022 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2022Compatibility Problem; Compatibility Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15511214 ↗
• MalfunctionJul 7, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT DURING INSPECTION IT WAS DISCOVERED THAT THE LOAN SET ARRIVED AT THE LOCAL WAREHOUSE WITH PROOF NO. 9 BROKEN. IT WAS CONFIRMED THAT THE DEVICE WAS NOT DAMAGED DURING SURGERY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) T-PAL TRIAL SPACER 10MM X 28MM 9MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14948619 ↗