T2 ALPHA 2341-1031SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327291025), received between Sep 4, 2020 and Oct 20, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "IN THIS CASE OF AN OPEN FRACTURE OF THE TIBIA TREATED WITH INTRAMEDULLARY NAILING, FLAP SURGERY BY PLASTIC SURGEONS WAS UNSUCCESSFUL, AND DUE TO POOR SKIN CONDITION, IT WAS DECIDED TO REMOVE THE CEMENT PORTION AND REPLACE THE NAIL WITH A SHORTER NAIL AT A LATER DATE."

  Patient problems: Scar Tissue

  MAUDE report 23342577 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE T2 ALPHA TIBIA IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF T2 ALPHA TIBIA. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6)2016 ¿ (B)(6)2024. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT (B)(6) HAD GENERALIZED PAIN.

  Patient problems: Pain

  MAUDE report 23311273 ↗
• MalfunctionSep 4, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED: "THERE WAS A FOREIGN MATERIAL LIKE HAIR BETWEEN FILM AND PACKAGING." "THE NAIL WAS USED FOR PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10496892 ↗