NA 2361-5050SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327381559), received between Apr 8, 2020 and Apr 2, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ORIF WAS PERFORMED FOR FEMORAL CONDYLE FRACTURE ON (B)(6) 2024. HOWEVER, IT WAS FOUND THAT FIXATION WAS NOT ACHIEVED ON (B)(6) 2024. THUS, REVISION SURGERY TO REMOVE THE DEVICES WAS PERFORMED ON (B)(6) 2024. THE DOCTOR TOLD THAT THE ORIGINAL FRACTURE WAS SEVERE, AND ALTHOUGH THE DEVICES WERE IMPLANTED IN HOPES OF REDUCING AND MAINTAINING THE FRACTURE, THE FRACTURE PART REMAINED UNSTABLE AFTER SURGERY."

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19026635 ↗
• MalfunctionNov 15, 2022Break; Fracture; Mechanical Jam; Break; Fracture; Mechanical Jam

  AS REPORTED: "DURING A T2 ALPHA GT PROCEDURE, AN ADVANCED LOCKING SCREW WAS USED, BUT IT BECAME STUCK WITH THE NAIL AND COULD NOT BE PULLED OUT OR ADVANCED. IT GOT STUCK IN THE MIDDLE OF INSERTION AND COULD NOT BE PULLED OUT DESPITE VARIOUS ATTEMPTS TO REMOVE IT. THE PROTRUDING PART WAS CRUSHED WITH A CARBIDE DRILL AS A LAST RESORT. THE REMAINDER OF THE SCREW WAS LEFT IN THE BODY." ADDITIONALLY, IT WAS REPORTED THAT THERE WAS A 60 MINUTE SURGICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15797423 ↗
• MalfunctionFeb 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "THE INITIAL OPERATION FOR TIBIAL TRUNK SURGERY WAS PERFORMED ON (B)(6) 2020. SINCE T2 ALPHA ADVANCED LOCKING SCREW WAS COMING OFF (SINCE UNKNOWN DATE). THE PATIENT WAS CAUSING THE INFECTION, AND THERE MAY BE SOME CAUSAL RELATIONSHIP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346641 ↗
• InjuryApr 8, 2020Migration; Migration

  THIS REPORT IS FOR THE SECOND SCREW BACK-OUT ("THE OTHER 2 DISTAL SCREWS"). AS REPORTED: "THE MOST DISTAL T2 ALPHA SCREW IN THE TIBIA NAIL BACKED OUT AND HAD TO BE REMOVED. THE SCREW WAS AN ADVANCED LOCKING SCREW AND WAS REMOVED IN CLINIC. TWO DAYS LATER, THE OTHER 2 DISTAL SCREWS (ADVANCED LOCKING SCREWS) ALSO BACKED OUT. THIS EVENT HAPPENED 2 AND 2.5 WEEKS POST OP".

  Patient problems: Failure of Implant; Injury

  MAUDE report 9941480 ↗