IPS 60-000-66-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888118095473), received between Feb 16, 2017 and Feb 16, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 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.

• InjuryFeb 16, 2017Loose or Intermittent Connection; Improper or Incorrect Procedure or Method

  PATIENT HAD LEFORT I AND BILATERAL SAGITTAL SPLIT OSTEOTOMIES. PATIENT SPECIFIC PLATES WERE PLACED IN BOTH THE RIGHT AND LEFT SIDE OF THE MAXILLA AND MANDIBLE. PATIENT HAD AN INFECTION IN RIGHT MANDIBULAR PLATE. BOTH LEFT AND RIGHT MANDIBULAR IMPLANTS WERE REMOVED DUE TO CONCERN BY DR. (B)(6). TWO SCREWS WERE NOTICED TO BE LOOSE WHEN PLATE WAS REMOVED. IT WAS NOTED THE PATIENT DID NOT HAVE THE BEST ORAL HYGIENE AND DID NOT KEEP THE SITE CLEAN. MAXILLA PLATES WERE LEFT IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 6335660 ↗