TRIGEN 71649538Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556338643), received between Apr 27, 2021 and Apr 27, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryApr 27, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED TO IMPLANT AN INTRAMEDULLARY NAIL, THE PATIENT EXPERIENCED PAIN. THE ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY; HOWEVER, THERE WAS NOTHING WRONG WITH THE NAIL. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Implant Pain

  MAUDE report 11730136 ↗

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