NA 03.620.075Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034717852), received between Jul 17, 2023 and Jul 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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.

• MalfunctionJul 17, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A PROCEDURE ON (B)(6), 2023, A NEWLY PURCHASED INSTRUMENT HAD ALREADY STARTED TO RUST FOLLOWING WASHING. A PHOTO OF THE DEVICE WAS AVAILABLE FOR REVIEW. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE THREADED REMOBILIZATION TOOL HAD SIGNS OF BROWN STAINS ALONG THE SURFACE OF THE THREADED SECTION. IT CANNOT BE CONFIRMED TO BE CORROSION OF THE DEVICE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A PANGEA THREADED REMOBILIZER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332638 ↗