NA 2361-5070SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327381504), received between Jun 10, 2020 and Apr 2, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 reports).

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 19027651 ↗
• InjuryMar 15, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "REP WAS NOTIFIED THAT AT 6-MONTH POST-OP FOLLOW-UP FOR A LEFT ALPHA TIBIAL NAIL, THE PROXIMAL ADVANCED LOCKING SCREW WAS BROKEN IN HALF. AS THERE ARE OTHER SCREWS HOLDING THE NAIL, AND THE BONE FRACTURE (WHICH THE NAIL WAS IMPLANTED TO ADDRESS) IS HEALING, THE SURGEON HAS NO CURRENT PLAN TO REVISE THE NAIL UNTIL/ UNLESS ANY ADVERSE AFFECT OCCURS WITH THE PATIENT. AT TIME OF REPORT, REP WAS NOT MADE AWARE OF ANY PATIENT COMPLAINTS. "

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 18917774 ↗
• InjuryApr 6, 2022Migration; Migration

  AS REPORTED: "ON (B)(6) 2022, REVISION SURGERY WAS PERFORMED DUE TO A T2 ALPHA ADVANCED LOCKING SCREW BACKING OUT OF A TIBIAL NAIL".

  Patient problems: Failure of Implant; Insufficient Information; Perforation

  MAUDE report 14022144 ↗
• MalfunctionJun 10, 2020Migration; Migration

  THE REPRESENTATIVE WAS PROVIDED A PICTURE OF AN X-RAY SHOWING A T2 ALPHA GREATER TROCH NAIL WITH THE DISTAL LOCKING SCREW BACKING OUT. SURGEON'S TEXT STATES: "WHY IS IT THAT THE LOCKING DISTAL SCREWS BACKED OUT BUT THE REGULAR SCREW DID NOT?" NO REVISION WAS REPORTED FOR THE PATIENT AT THIS TIME.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 10140776 ↗