TRIGEN 71649744Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556340998), received between Sep 22, 2021 and Sep 22, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K092748, K243364); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "IT WAS REPORTED THAT, 8 MONTHS AFTER A PROCEDURE HAD BEEN PERFORMED WITH TRIGEN TRAPTAN 11.5MM X 44CM LEFT TO TREAT A SIMPLE LONG BONE FRACTURE IN THE PROXIMAL REGION OF THE FEMUR, THE PATIENT EXPERIENCED PAIN AROUND THE GREATER TROCHANTER. THE TRIGEN TRAPTAN 11.5MM X 44CM LEFT WAS EXPLANTED, BUT THERE IS NO CONFIRMATION IF ANOTHER NAIL WAS USED IN EXCHANGE. AFTER 5 MONTHS FROM THE NAIL'S EXPLANTATION, A SUBSEQUENT UNION OF THE FRACTURE WAS REPORTED AS A GENERAL OUTCOME. 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.

  Patient problems: Limb Fracture; Pain

  MAUDE report 12512553 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092748, K243364. One submission often covers many models, so check the product and lot details in each record.

• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690