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NA 446.22Recalls & reported problems

Synthes GmbH · 1.5MM TI ORBITAL RIM PLATE 12 HOLES · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587051680), received between Mar 24, 2023 and Mar 24, 2023 — classified as 1 malfunction.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2023 THE VETERINARY SURGEON REPORTED THAT HARDWARE BECAME INFECTED IN A DOG PATIENT. PATIENT HAD MULTIPLE CRANIOFACIAL FRACTURES. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. ALL THE HARDWARE/IMPLANTS WILL BE REMOVED ON (B)(6) 2023, THAT WERE USED IN PREVIOUS SURGERY. UNSURE WHICH ONES CAUSED THE INFECTION AND WILL BE REMOVING ALL OF THE PLATES & SCREWS. NO NEW HARDWARE WILL BE IMPLANTED AT THIS TIME. THIS REPORT IS FOR ONE (1) 1.5MM TI ORBITAL RIM PLATE 12 HOLES. THIS IS REPORT 6 OF 14 FOR COMPLAINT.

    Patient problems: Unspecified Infection

    MAUDE report 16611514 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.