TRIGEN 71640634Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556340196), received between Sep 27, 2021 and May 27, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING SURGERY THE META-TAN 10MM X 34CM RIGHT WAS NOT ALLOWING A 5.0MM SCREW TO PASS THROUGH IT. THE SCREWS GOT STUCK IN THE NAIL. THE PROCEDURE WAS COMPLETED, WITH A SIGNIFICANT DELAY, USING THE SAME NAIL. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520273 ↗
• InjurySep 27, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT, AFTER TRAUMA SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED PAIN ON (B)(6) 2021. THIS ADVERSE EVENT WAS TREATED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2021. THE SURGEON DETERMINED THIS FAILURE WAS DUE TO A NON-UNION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 12537409 ↗

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