TRIGEN 71649740Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556340899), received between May 31, 2017 and Jul 11, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionJul 11, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, AFTER REMOVING THE JIG, IT WAS NOTICED THAT THE INTEGRATED SCREW HAD MISSED THE META-TAN 11.5MM X 40CM LEFT. CONSIDERABLE EFFORTS WERE REQUIRED TO REPOSITION THE NAIL AND THE SCREW. THE PROCEDURE RESUMED AFTER A NON-SIGNIFICANT DELAY, USING THE SAME NAIL. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727230 ↗
• MalfunctionMay 31, 2017Difficult to Remove; Split

  IT WAS REPORTED THAT UPON TAKING FINAL XRAYS IT WAS NOTICED ON THE LATERAL THAT THE SCREWS HAD SPLIT APART AND ALMOST LOOKED LIKE THEY ARE OVERLAPPING. THE SURGEON TRIED TO TAKE THE SCREW OUT AND REINSERT BUT WAS NOT SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6601237 ↗

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