TRIGEN 71655132Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010585554), received between Aug 22, 2019 and Sep 29, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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, FOLLOWING AN INTRAMEDULLARY NAIL FIXATION OF A DISPLACED OBLIQUE FRACTURE OF THE SHAFT OF THE RIGHT TIBIA 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 20329553 ↗
• InjurySep 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A LEFT ORIF WITH INTRAMEDULLARY NAIL FIXATION PERFORMED ON (B)(6) 2021 TO TREAT A DISTAL TIBIAL FRACTURE SUSTAINED AS A CONSEQUENCE OF A MOTOR VEHICLE COLLISION, THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2021 DUE TO WORSENING PAIN IN THE LEFT LOWER EXTREMITY AND DIFFICULTY WALKING. THE INTRAMEDULLARY NAIL WAS EXCHANGED ON (B)(6) 2021 DUE TO SYMPTOMATIC NONUNION. 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: Ambulation or Postural Difficulties; Nonunion/Delayed-union Bone Fracture

  MAUDE report 20329509 ↗
• InjuryAug 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DAY AFTER SURGERY OF INTRAMEDULLARY 10×320 NAILING TRIGEN META-NAIL, THE PATIENT WAS TAKEN TO EMERGENCY DUE TO PERSISTENT OEDEMA AND PROGRESSIVE HYPOESTHESIA WITH DORSIFLEXION¿S IMPAIRMENT. (CTA) REVEALED THE PRESENCE OF A PSA AND AVF. ENDOVASCULAR APPROACH UNDER LOCAL ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8921411 ↗