Custom 4 Hole VLC Gridlock Plate 300-50-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812926022451), received between May 12, 2017 and May 12, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K130964); they may or may not involve this specific model.

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.

• MalfunctionMay 12, 2017Break; Positioning Problem

  A PATIENT REPORTED PAIN IN HER FOOT. THIS PATIENT HAD A LAPIDUS PROCEDURE COMPLETED ON (B)(6) 2016 WITH A 300-50-004 PLATE. THE DOCTOR TOOK X-RAYS AND COULD TELL A SCREW WAS BACKING OUT AND THE 300-50-004 PLATE WAS BROKEN INSIDE THE PATIENT. ON (B)(6) 2017, THE DOCTOR REMOVED THE 300-50-004 PLATE. SINCE THE BONE HAD NOT COMPLETELY HEALED AND THERE WAS NO FUSION, THE DOCTOR REPLATED THE SURGICAL SITE. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6563355 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130964. One submission often covers many models, so check the product and lot details in each record.

• Z-1609-2020 · Jul 19, 2018 · Terminated
  Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm name on the label is Trilliant