Tiger 202-30-028Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812926021775), received between Feb 22, 2021 and Feb 22, 2021 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (K112737); 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 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, A TRILLIANT INDEPENDENT SALES REPRESENTATIVE REQUESTED A 212-40-003 (3.0/4.0MM HEADLESS DRIVER BIT) TO REPLACE HER CURRENT DRIVER THAT BROKE DURING A PREVIOUS REMOVAL SURGERY WITH DOCTOR 1 AT FACILITY X. THE SALES REPRESENTATIVE STATED THAT DURING A REMOVAL CASE ON (B)(6) 2021, DOCTOR 1 WAS REMOVING A COMPETITOR'S PLATE / ACCESSORY IMPLANTS AND A TRILLIANT HEADLESS CANNULATED SCREW (202-30-028, 3.0MM X 28MM TIGER HEADLESS CANNULATED SCREW) INSERTED AS THE INTERFRAGMENTARY SCREW. THE ORIGINAL IMPLANTATION OCCURRED ON (B)(6) 2019 WITH PREVIOUS TRILLIANT REPRESENTATION. THE PATIENT, AT THE TIME OF IMPLANTATION, WAS (B)(6) YEARS OLD (FEMALE, DOB: (B)(6), WEIGHT REMAINS UNKNOWN). THE PATIENT DID NOT COME IN EXPERIENCING PAIN, BUT DOCTOR 1 NOTICED A FOOT DEFORMITY PRESENT IN THE PATIENT AND OPTED TO REMOVE THE ORIGINAL PLATING. UPON REMOVAL, DOCTOR 1 HAD DIFFICULTY REMOVING THE 202-30-028 OUT OF THE SURGICAL SITE DUE TO BONE GROWTH OVER THE TIP OF THE SCREW. DOCTOR 1 PROVIDED CLEARANCE TO INSERT THE 212-40-003 INTO THE SCREW TO BEGIN BACKING IT OUT. AFTER A FEW TURNS, THE TIP OF THE 212-40-003 BROKE OFF INTO THE SURGICAL SITE. DOCTOR 1 FLUSHED THE SITE, HOWEVER HE DID NOT

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11362449 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112737. One submission often covers many models, so check the product and lot details in each record.

• 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-0609-2017 · Sep 2, 2016 · Terminated
  Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgic
• Z-2464-2015 · Jul 20, 2015 · Terminated
  Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System an