TRIGEN 71653038Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010548207), received between Dec 20, 2022 and Dec 20, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM A SURGICAL SITE INFECTION AND NON-UNION AFTER HAVING A FRACTURE FIXATION SURGERY OF THE RIGHT FEMUR USING THE TRIGEN RETROGRADE FEMORAL NAIL SYSTEM. THE PATIENT WAS TREATED WITH SURGICAL IRRIGATION AND DEBRIDEMENT AND WOUND VAC. NO HARDWARE REVISION SURGERY WAS SCHEDULED, AND THE PATIENT WAS LOST TO FOLLOW UP. IT IS UNKNOWN IF THE PATIENT ACHIEVED BONE UNION. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT. WE DO NOT HAVE THE OPPORTUNITY TO IDENTIFY INDIVIDUAL HCPS AND REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION.

  Patient problems: Bacterial Infection; Fever; Nonunion/Delayed-union Bone Fracture; Osteomyelitis; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 16014354 ↗