NA 1891-5030SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540201911), received between Apr 5, 2019 and Dec 14, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 18, 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.

• MalfunctionDec 14, 2022Inaccurate Information; Inaccurate Information

  AS REPORTED: "SCREW OF T2 SYSTEM DID NOT HAVE THE LENGTH MARKED ON THE PACKAGE AND THE SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15981885 ↗
• MalfunctionApr 5, 2019Device Contamination with Chemical or Other Material; Packaging Problem; Packaging Problem

  WHEN NURSE OPENED THE STERILE SCREW BOX, EN SHE SAW A LITTLE HAIR( LOOKS LIKE A EYE LASH OR EYEBROW). SURGERY WAS DELAYED A LITTLE - ACCORDING TO DETAILS RECEIVED LESS THAN 15 MIN.

  Patient problems: No Information

  MAUDE report 8487570 ↗