10 Hole Contoured VL Gridlock Fibula Plate 300-61-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812926027586), received between May 5, 2021 and May 5, 2021 — classified as 1 injury.

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.

• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 04/08/2021, A TRILLIANT SURGICAL INDEPENDENT SALES REPRESENTATIVE CALLED A TRILLIANT SURGICAL SALES SUPPORT SPECIALIST REPORTING OF A REMOVAL SCHEDULED ON (B)(6) 2021 WITH DOCTOR 1 AT FACILITY 1 ON A (B)(6) YEAR-OLD MALE PATIENT (DOB: (B)(6)). THE REMOVAL WAS SCHEDULED DUE TO LOCALIZED INFECTION ASSUMED TO BE AT THE SITE WHERE A COMPETITOR'S TIGHTROPE WAS IMPLANTED. DOCTOR 1 OPTED TO REMOVE THE ENTIRE CONSTRUCT AS WELL. THE ORIGINAL IMPLANTATION OCCURRED ON (B)(6) 2021 ALSO AT FACILITY 1 WITH DOCTOR 1. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN WHEN THE PATIENT CAME IN REPORTING OF LOCALIZED PAIN. AS SCHEDULED, ON (B)(6) 2021 , THE REMOVAL OCCURRED AND ALL TRILLIANT SURGICAL HARDWARE WAS REMOVED; FUSION HAD OCCURRED. THE FOLLOWING ITEMS WERE EXPLANTED: 300-61-006 (10 HOLE CONTOURED VL GRIDLOCK FIBULA PLATE), 304-35-022 (3.5MM X22MM GRIDLOCK ANKLE SCREW), 305-35-018 (3.5MM X 18MM GRIDLOCK ANKLE LOCKING SCREW), 305-35-014 (3.5MM X 14MM GRIDLOCK ANKLE LOCKING SCREW), AND 304-35-014 (3.5MM X 14MM GRIDLOCK ANKLE SCREW). ALL ITEMS WILL NOT BE RETURNED DUE TO HOSPITAL PROTOCOL. IT IS ALSO TO BE NOTED THAT TWO (2) 4.0 TIGER CANNULATED SCREWS WERE REMOVED AS WELL, HOWEVER THES

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11778937 ↗

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