7 Hole VL Gridlock Fibula Plate 300-60-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812926025438), received between Jan 20, 2022 and Jan 20, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K160177); 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.

• InjuryJan 20, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 12/23/2021, DJO F&A INDEPENDENT SALES REPRESENTATIVE EMAILED DJO F&A SALES SUPPORT SPECIALIST TO REPORT OF A REMOVAL CASE INCLUDING A 304-35-020 (3.5MM X 20MM GRIDLOCK ANKLE SCREW), (2) 305-35-016 (3.5MM X 16MM GRIDLOCK ANKLE LOCKING SCREW), 305-35-014 (3.5MM X 14MM GRIDLOCK ANKLE LOCKING SCREW), 304-35-014 (3.5MM X 14MM GRIDLOCK ANKLE SCREW), (2) 304-35-012 (3.5MM X 12MM GRIDLOCK ANKLE SCREW) AND 300-60-001 (7 HOLE VL GRIDLOCK FIBULA PLATE) DUE TO THE PATIENT REPORTING "PLATE IRRITATION" AT FACILITY 1 BY DOCTOR 1 ON A (B)(6) YEAR OLD FEMALE PATIENT. THE IMPLANTATION OCCURRED ON (B)(6) 2021 BY DOCTOR 1 AT FACILITY 1. X-RAYS WERE OBTAINED OF THE ORIGINAL IMPLANTATION AND AFTER THE REMOVAL. DJO F&A INDEPENDENT SALES REPRESENTATIVE STATED THAT "EVERYTHING HEALED" FROM THE ORIGINAL IMPLANTATION AND THE REMOVAL WAS DUE TO "PLATE IRRITATION". DJO F&A INDEPENDENT SALES REPRESENTATIVE WAS NOT ABLE TO COLLECT THE REMOVED PARTS, 304-35-020, 305-35-016, (2) 305-35-014, 304-35-014, (2) 304-35-012, AND 300-60-001, AS THE FACILITY RETAINS THEM FOR THEIR OWN QUALITY ASSESSMENT AND THEREFORE, WILL NOT BE RETURNED TO CORPORATE FOR FURTHER REVIEW.

  Patient problems: Pain

  MAUDE report 13309608 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160177. One submission often covers many models, so check the product and lot details in each record.

• Z-1613-2020 · Jul 19, 2018 · Terminated
  Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Ankle Plating System, Model 320-01-100. The firm name on the label is Tri