NA 0250080341Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327058277), received between Aug 21, 2018 and Aug 21, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionAug 21, 2018Break

  IT WAS REPORTED THAT THE METAL LAYER BROKE OUTSIDE OF THE PATIENTS BODY. NO PIECES FELL INTO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7802972 ↗
• InjuryAug 21, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ADDITIONAL SURGERY WAS PERFORMED TO REMOVE A METALLIC LAYER FROM INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7802910 ↗