Tiger 202-30-026Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812926021768), received between May 5, 2021 and May 5, 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.

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

  ON 04/07/2021, FACILITY 1'S MATERIALS MANAGEMENT EMAILED TO OUR ORDER MANAGEMENT TEAM FOR A 212-40-003 (3.0MM TIGER CANNULATED DRIVER BIT) FOR AN UPCOMING REMOVAL OF A HEADLESS SCREW AT THEIR FACILITY. THE MATERIALS MANAGEMENT REPORTED THAT THE ICD-10 CODING OF THE PROCEDURE POINTED THAT THE HEADLESS SCREW WAS SCHEDULED TO REMOVE DUE TO PATIENT PAIN DUE TO INTERNAL ORTHOPEDIC PROSTHETIC DEVICES. UPON INITIAL INTERVIEW, TRILLIANT SURGICAL'S SALES SUPPORT SPECIALIST OBTAINED THE FOLLOWING DETAILS: THE DATE OF ORIGINAL IMPLANTATION OF THE 202-30-026 (3.0 X 26MM TIGER CANNULATED HEADLESS SCREW) WAS ON (B)(6) 2015 AT FACILITY 1 BY DOCTOR 1 ON A (B)(6)-YEAR-OLD FEMALE PATIENT (DOB: (B)(6), WEIGHT: (B)(6) LBS). THE SCHEDULED REMOVAL IS ON (B)(6) 2021, ALSO AT FACILITY 1 WITH DOCTOR 1. FURTHER REMOVAL DETAILS SHALL BE OBTAINED IN A FOLLOW UP INTERVIEW WITH MATERIALS MANAGEMENT. ADDITIONAL INFORMATION RECEIVED 04/28/2021: THE SURGEON WAS UNABLE TO REMOVE ANY HARDWARE ON [(B)(6) 2021]. IT WAS BURIED TOO DEEP, HE DIDN'T WANT TO COMPROMISE THE BONE. NO PATIENT NONCOMPLIANCE, BONE QUALITY, OR COMORBIDITIES NOTED.

  Patient problems: Pain

  MAUDE report 11776474 ↗

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