NA 03.100.121Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982071187), received between Sep 14, 2022 and Sep 14, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Compatibility 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2022Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN INTERNAL DESIGN VALIDATION LAB FOR THE NEW PRODUCT DEVELOPMENT, THE TEAM AND THE SURGEON NOTICED THAT THE SPIKED RECTANGULAR DISK WAS NOT RETAINING ON THE NPD BALL SPIKE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE SPIKED RECTANGULAR DISK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15416804 ↗