Tiger 205-55-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812926024097), received between Feb 27, 2020 and Feb 27, 2020 — classified as 1 injury.

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

4 other recalls cover devices cleared under the same FDA submission (K153338); 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 16, 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.

• InjuryFeb 27, 2020Migration; Migration

  ON (B)(6) 2020, A TRILLIANT SURGICAL SALES REPRESENTATIVE REPORTED TO TRILLIANT SURGICAL SALES SUPPORT THAT A REMOVAL CASE THAT OCCURRED WITH DOCTOR 1 ON (B)(6) 2020 INVOLVING A 205-55-040 (5.5MM X 40MM STTCS; LOT TSL002020). DOCTOR 1 ORIGINALLY IMPLANTED THE 205-55-040 FOR A 5TH METATARSAL FRACTURE IN A PATIENT WITH REPORTEDLY POOR BONE QUALITY ON (B)(6) 2019. A WEEK POST-OP, THE PATIENT PREMATURELY WALKED WHICH IS WHAT DOCTOR 1 BELIEVES CAUSED THE SCREW TO BEGIN BACKING OUT. A REMOVAL CASE WAS BOOKED FOR (B)(6) 2020 TO REMOVE THE BACKED OUT 205-55-040 AND TO PLATE THE 5TH METATARSAL WITH TRILLIANT SURGICAL'S ARSENAL 5TH MET HOOK PLATE. THE REMOVAL/PLATING CASE WENT ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9764032 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153338. One submission often covers many models, so check the product and lot details in each record.

• Z-1612-2020 · Jul 19, 2018 · Terminated
  Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Sur
• Z-1606-2020 · Jul 19, 2018 · Terminated
  Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and (2) Combinatio
• Z-1605-2020 · Jul 19, 2018 · Terminated
  Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger
• Z-0960-2017 · Dec 8, 2016 · Terminated
  Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses,