PINNACLE 2218-40-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295430025), received between Mar 5, 2020 and Aug 15, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 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 15, 2025Break; Break

  IT WAS REPORTED THAT THE TRIAL BROKE DURING EXTRACTION AFTER TRIALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815717 ↗
• MalfunctionNov 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT THE LINER TRIALS FOR THE SIZE 40 WERE NOT SEATING PROPERLY. SURGEON REQUESTS NEW SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12898278 ↗
• MalfunctionNov 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LINER TRIAL WOULDN'T SEAT IN THE CUP AND THE SURGEON ASKED TO GET A SET IN THAT WOULD WORK. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883250 ↗
• MalfunctionMar 5, 2020Break; Break

  IT WAS REPORTED THAT THE SIZE 58 LINER TRIAL FOR A 40 HEAD, WAS BROKEN WHERE THE METAL MET THE PLASTIC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9794355 ↗