Large VLC "L" Plate Left 300-56-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812926025407), received between Jul 17, 2017 and Oct 18, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2017Failure To Adhere Or Bond

  PLATE WAS IMPLANTED IN MID 2016. PATIENT REPORTED PAIN, X-RAY REVEALED THE PLATE WAS BROKEN. SURGEON NOTED THAT THERE WAS NO UNION, ONLY FIBROUS UNION. REVISION WAS PERFORMED ON (B)(6) 2017. SURGEON REPORTED THAT THE PATIENT WAS NON-COMPLIANT.

  Patient problems: Pain

  MAUDE report 6958825 ↗
• MalfunctionSep 26, 2017Failure To Adhere Or Bond; Device Dislodged or Dislocated

  PLATE WAS IMPLANTED IN (B)(6) 2016. PATIENT REPORTED PAIN, X-RAY REVEALED THE PLATE WAS BROKEN. SURGEON NOTED THAT THERE WAS NO UNION, ONLY FIBROUS UNION. REVISION WAS PERFORMED ON (B)(6) 2017. SURGEON REPORTED THAT THE PATIENT WAS NON-COMPLIANT.

  Patient problems: Pain

  MAUDE report 6895419 ↗
• MalfunctionJul 17, 2017Crack

  DOCTOR REMOVED A LARGE VLC "L" PLATE (LEFT) BECAUSE OF A NON-UNION. THE PLATE WAS CRACKED, ACCORDING TO THE REP. THE DOCTOR REMOVED THE PLATE WITHOUT ANY COMPLICATIONS. HE PERFORMED A REVISION LAPIDUS PROCEDURE AND USED A PARAGON 28 PLATE TO FINISH THE CASE. THE REP WAS NOT ABLE TO KEEP THE PLATE BECAUSE THE PATIENT REQUESTED TO KEEP IT. THE REP WAS NOT ABLE TO DETERMINE THE INITIAL IMPLANT DATE THOUGH IT WSA DETERMINED TO BE A YEAR TO A YEAR AND A HALF AGO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6716715 ↗

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