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NA 446.51Recalls & reported problems

Synthes GmbH · 1.5MM TI OBLIQUE L-PLATE 2 X 3 HOLES-RIGHT · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 10887587051826), 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 MARCH, 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 OBLIQUE L-PLATE 2 X 3 HOLES-RIGHT. THIS IS REPORT 5 OF 14 FOR COMPLAINT.

    Patient problems: Unspecified Infection

    MAUDE report 16611552 ↗

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Sources and updates

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