IPS 60-000-19-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888118100054), received between Nov 5, 2019 and Jan 21, 2020 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED TO ADDRESS PATIENT INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9610266 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PEEK IMPLANT WAS REMOVED TO ADDRESS PATIENT INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9456824 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRODUCT WAS REMOVED DUE TO PATIENT CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 9280132 ↗