TRIGEN 71649842Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556342046), received between Dec 6, 2024 and Dec 6, 2024 — 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.

• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A LEFT FEMUR ORIF SURGERY PERFORMED ON (B)(6) 2020 DUE TO AN IMPENDING PATHOLOGIC FRACTURE SECONDARY TO RELAPSED MYELOMA, THE PATIENT SUSTAINED SYMPTOMATIC NON-UNION AT THE SITE OF DISTAL FEMUR LESION WHICH REQUIRED A REVISION SURGERY WITH NAIL EXCHANGE ON (B)(6) 2022. 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 20868423 ↗

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