ASNIS 604638SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540089748), received between May 12, 2021 and Dec 26, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Handling 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT AN EXPIRED DEVICE WAS IMPLANTED INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048863 ↗
• InjuryMay 12, 2021Device Handling Problem; Device Handling Problem

  THE SURGEON WAS NOTIFIED THAT THE CONSIGNMENT DEVICE HE IMPLANTED WAS EXPIRED; THE DECISION WAS MADE TO REMOVE THE SCREW FROM THE PATIENT, AS THE PATIENT WAS STILL INTUBATED IN THE ICU. SWABS WERE TAKEN TO CHECK FOR INFECTION; NO INFECTION WAS FOUND ON THE SCREW OR IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11815824 ↗