TRIGEN 71655134Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010585561), received between Sep 29, 2024 and Dec 13, 2024 — 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 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A RIGHT IMN FIXATION SURGERY PERFORMED ON (B)(6) 2016 DUE TO A DISPLACED COMMINUTED FRACTURE OF SHAFT OF THE TIBIA, THE PATIENT REQUIRED THE REMOVE OF A DISTAL INTERLOCKING SCREW AS WELL AS ONE OF THE PROXIMAL LOCKING SCREW DUE TO SYMPTOMATIC HARDWARE. THE SURGEON DIDN'T REMOVE ALL THE HARDWARE AS THERE WAS NOT COMPLETE CONSOLIDATION OF THE RIGHT TIBIAL SHAFT. 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: Implant Pain

  MAUDE report 20924490 ↗
• InjurySep 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN INTRAMEDULLARY NAIL FIXATION OF A DISPLACED COMMINUTED FRACTURE OF SHAFT OF THE RIGHT FEMUR PERFORMED ON AN UNKNOWN DATE, THE PATIENT SUSTAINED NONUNION OF THE FRACTURE. 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: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20329577 ↗