TRIGEN 71653036Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010548191), received between Jul 26, 2022 and Dec 20, 2022 — classified as 2 injuries.

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 2 most recent of 2 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 NON-UNION AND KNEE PAIN AFTER HAVING A FRACTURE FIXATION SURGERY OF THE RIGHT FEMUR USING THE TRIGEN RETROGRADE FEMORAL NAIL SYSTEM. THE PATIENT UNDERWENT A REVISION SURGERY TO EXCHANGE THE NAIL ON (B)(6) 2021. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN. 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: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 16015965 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM FRACTURE NONUNION 135 WEEKS AFTER BEING TREATED WITH A TRIGEN RETROGRADE FEMORAL NAIL SYSTEM FOR A LEFT FEMORAL FRACTURE ON (B)(6) 2016. THE SURGEON RECOMMENDED ADDITIONAL SURGERY TO ADDRESS THE ISSUE, BUT THE PATIENT´S DAUGHTER PREFERRED TO AVOID IT DUE TO PATIENT´S COMORBIDITIES. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN. THIS INFORMATION WAS PROVIDED AS PART OF A TRIGEN PMCF STUDY. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15108896 ↗