ACTIS 3010-01-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295548614), received between Jun 8, 2023 and Aug 2, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2023Material Discolored; Device-Device Incompatibility; Naturally Worn; Material Discolored; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE CALCAR PLANAR AND NECK TRIAL GOT STUCK ON THE SIZE 2 BROACH TRUNION. THERE WAS SOME DELAY IN THE CASE IN ORDER TO REMOVE THE NECK TRIAL FROM THE BROACH. NO PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17443045 ↗
• MalfunctionJun 8, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090311 ↗
• MalfunctionJun 8, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090280 ↗
• MalfunctionJun 8, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT THE BROACH BROKE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090254 ↗