TRIGEN 71655138Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010585608), received between Feb 8, 2018 and Sep 29, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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. How this data works · Data updated Oct 13, 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.

• InjurySep 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TIBIAL NAIL EXCHANGE WITH DEBRIDEMENT PERFORMED ON (B)(6) 2019 DUE TO POLYMICROBIAL INFECTION (INCLUDING MRSA, E. FAECALIS AND S. VIRIDANS), THE PATIENT WAS READMITTED ON (B)(6) 2019 FOR I&D DUE TO EVIDENCE OF SURGICAL SITE INFECTION WITH PURULENT MRSA ON THE RIGHT LOWER EXTREMITY. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 20329506 ↗
• MalfunctionJul 29, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, A 3.0MM GUIDE ROD BECAME INCARCERATED IN A TRIGEN META TIBIAL NAIL 10MM X 38CM. IN ORDER TO COMPLETE THE PROCEDURE, BOTH THE NAIL AND GUIDE ROD WERE REMOVED AND REPLACED. SURGERY WAS RESUMED AFTER A DELAY GREATER THAN 30 MIN. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135800 ↗
• InjuryFeb 8, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A REVISION SURGERY IS SCHEDULED. THIS IS BECAUSE IN OR EVERYTHING WENT WELL, BUT FROM POST-OPERATIVE PICTURES IT WAS SEEN, THAT THE TIP OF MOST PROXIMAL SCREW IS IN THE JOINT.

  Patient problems: No Information

  MAUDE report 7251567 ↗