IPS 60-660-01-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888118095022), received between May 26, 2017 and May 7, 2018 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 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.

• InjuryMay 7, 2018Break; Break

  IT WAS REPORTED THAT AN IPS MANDIBLE PLATE BROKE. THE PATIENT IS A CANCER SURVIVOR AND HAS OSTEONECROSIS OF THE MANDIBLE DUE TO RADIATION TREATMENTS. THE PLATE IS EXPECTED TO BE REMOVED AND REPLACED ON AN UNKNOWN DATE.

  Patient problems: Impaired Healing

  MAUDE report 7490237 ↗
• InjuryMay 26, 2017Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  PLATE WAS IMPLANTED INTO THE PATIENT AFTER A TUMOR RESECTION OF THE JAW. AFTER IMPLANTATION PLATE FRACTURED IN HALF BY THE ANGLE OF THE MANDIBLE. THERE WAS NO TRAUMA TO THE AREA AND NOTHING THAT THE DOCTOR KNEW OF THAT WOULD HAVE CAUSED THE BREAK.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6593892 ↗