PANGEA 541037Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327606522), received between Nov 24, 2025 and Nov 24, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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.

• MalfunctionNov 24, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "THE PRODUCTS IN QUESTION ARE THE 3.5MM NARROW COMPRESSION PLATE T15, (541037 7 HOLE PLATE FOR EXAMPLE) AND THE SHORTER T15 CORTICAL SCREWS (661412 12MM SCREW FOR EXAMPLE). I WATCHED THE SURGEON DRILL THROUGH BOTH CORTICES ONCE USING THE VA GUIDE (542028) IN WHAT LOOKED LIKE A PERPENDICULAR TO THE PLATE TRAJECTORY. WE CONFIRMED IT WAS A 2.5MM DRILL USED. THE SCREW WOULD CONTINUE TO SPIN IN THE HOLE UPON INSERTION, THIS HAPPENED TWICE. WE THEN USED A LONGER SCREW AND THE SAME HAPPENED AGAIN. THE SURGEON THINKS IT'S BECAUSE THE PITCH OF THE SCREWS ARE INFERIOR AND HENCE ON SMALLER LENGTHS THEY DON'T GET AS GOOD AS PURCHASE AS WHAT HE USES. ANOTHER COMMENT WAS THAT THE SCREW HEAD LOOKED TOO SMALL COMPARED TO THE DCP HOLE. THIS WAS A PROBLEM WHEN A SCREW WAS INSERTED ON AN ANGLE AWAY FROM THE FRACTURE SITE. THE SURGEON FOUND THAT UPON TIGHTENING THE CORTICAL SCREW IN THIS TRAJECTORY THAT THE SPACE BETWEEN THE SCREW HEAD AND THE BOTTOM OF THE PLATE WAS VERY LOW AND HE WAS WORRIED ABOUT SCREW PULL THROUGH ON THE PLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639301 ↗