Custom 5 Hole VLC Gridlock Plate 300-50-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812926025346), received between Apr 28, 2017 and Dec 14, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2017Break

  ONE OF TRILLIANT'S SALES REPRESENTATIVES WAS INFORMED BY (B)(6) HOSPITAL THAT A 300-50-008 PLATE WAS BROKEN IN A PATIENT THAT HAD UNDERGONE SURGERY ON (B)(6) 2017. THE PATIENT CAME IN FOR POST-OP VISIT (2-3 WEEKS AFTER THE SURGERY). AT THIS TIME, THE SURGEON NOTICED SOME SWELLING AND AFTER TAKING X-RAYS NOTICED THE PLATE WAS BROKEN. THE 300-50-008 PLATE WAS REMOVED FROM THE PATIENT ON (B)(6) 2017 DURING A REVISION CASE AS A FUSION HAD NOT OCCURRED.

  Patient problems: Failure of Implant; Swelling

  MAUDE report 7119758 ↗
• MalfunctionApr 28, 2017Break; Difficult to Remove

  THE PATIENT EXPERIENCED PAIN AFTER HAVING AN MPJ FUSION. THE DOCTOR DECIDED TO REMOVE THE 300-05-008 PLATE FROM THE PATIENT AS THERE WAS A NON-UNION. DURING REMOVAL OF THE HARDWARE, THREE OF THE FIVE NON-LOCKING SCREWS BROKE AND THEY WERE UNABLE TO BE REMOVED FROM THE PATIENT. THE DOCTOR WAS UNSURE WHEN THE SCREWS BROKE AS THEY MIGHT HAVE BEEN BROKEN PRIOR TO THE REMOVAL. THE PORTIONS OF THE 3 BROKEN SCREWS REMAIN IN THE PATIENT. THE DOCTOR REPLACED THE HARDWARE WITH A SILASTIC IMPLANT.

  Patient problems: Device Embedded In Tissue or Plaque; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 6530930 ↗

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