Tiger 200-24-028Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812926020815), received between Dec 12, 2019 and Jul 20, 2020 — classified as 2 injuries.

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

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

• InjuryJul 20, 2020Migration; Migration

  ON (B)(6) 2020, A TRILLIANT SURGICAL SALES REPRESENTATIVE CALLED TO REPORT ON THE REMOVAL OF A MINIMALLY INVASIVE BUNION (MIB) CONSTRUCT DUE TO REPORTED PATIENT PAIN AND A PALPABLE BUMP OVER THE SURGICAL SITE APPEARING 7 MONTHS POST-OPERATIVELY. THE MIB CONSTRUCT WAS ORIGINALLY IMPLANTED AT FACILITY 1 ON (B)(6) 2019 BY DOCTOR 1 ON A (B)(6)-YEAR-OLD FEMALE, WEIGHING (B)(6) POUNDS. DOCTOR 1 REPORTED SHE FIRST MET WITH THE PATIENT REGARDING THE PAIN ON (B)(6) 2020. AT THIS TIME, A BUMP COULD BE SEEN ABOVE THE SURGICAL SITE WHERE THE CONSTRUCT WAS IMPLANTED, LATER CONFIRMED TO INDICATE THE IMPLANTED 200-24-028 (2.4MM X 28MM TIGER CANNULATED SCREW) HAD BEGUN TO BACK OUT OF THE 300-70-002 (MINIMALLY INVASIVE BUNION PLATE, LEFT) PROXIMAL INTERFRAGMENTARY HOLE. THE REMOVAL CASE WAS SCHEDULED FOR (B)(6) 2020 WITH THE INTENTION OF JUST REMOVING THE 200-24-028. DURING THE (B)(6) 2020 REMOVAL CASE, DOCTOR 1 WENT TO REMOVE THE 200-24-028 WITH A 210-24-008 (2.0/2.4MM TIGER CANNULATED SLIP FIT DRIVER) WHEN THE CRUCIFORM HEAD OF THE SCREW STRIPPED. NOT BEING ABLE TO UTILIZE THE DRIVER ANYMORE, DOCTOR 1 TRIED TO WORK THE SCREW OUT USING A RONGEUR. THE SCREW THEN BROKE. DOCTOR 1 HAD THE CIRCULATING

  Patient problems: Impaired Healing; Pain

  MAUDE report 10297002 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ON (B)(6) 2019, A TRILLIANT SURGICAL SALES REPRESENTATIVE EMAILED IN TO TRILLIANT SURGICAL SALES SUPPORT WITH A TEXT MESSAGE THREAD FROM DOCTOR 1 STATING THAT A PATIENT WAS REPORTING OF PAIN FROM THE LAG SCREW FROM A PREVIOUS PROCEDURE UTILIZING THE MINIMALLY INVASIVE BUNION (MIB) PLATING SYSTEM. DOCTOR 1 SCHEDULED A REMOVAL TO OCCUR ON (B)(6) 2019 TO REMOVE THE TIGER CANNULATED SCREW FROM THE SURGICAL SITE. THE ORIGINAL IMPLANTATION OCCURRED ON (B)(6) 2019 AT FACILITY X ON A 64-YEAR-OLD FEMALE PATIENT. THE LAG SCREW (TO BE LATER REMOVED) WAS A 2.4MM X 28MM TIGER CANNULATED SCREW (200-24-028) UTILIZED FROM MINIMALLY INVASIVE BUNION PLATING SYSTEM LOANER #2, WHICH WAS PREVIOUSLY PROVIDED FROM CORPORATE FOR THE AFOREMENTIONED CASE. THE SALES REPRESENTATIVE WILL BE PRESENT AT THE REMOVAL CASE AND SHALL PROVIDE ANY ANCILLARY DETAILS ABOUT THE REMOVAL AND RETURN THE 200-24-028 FOR FURTHER REVIEW. ON (B)(6) 2019, SALES SUPPORT FOLLOWED UP WITH THE SALES REPRESENTATIVE ABOUT THE AFOREMENTIONED REMOVAL. THE REMOVAL TOOK PLACE ON (B)(6) 2019 IN DOCTOR 1'S OFFICE. THE SALES REPRESENTATIVE STATED THAT DOCTOR 1 TEXTED HIM AFTER THE REMOVAL THAT "THE SCREW CAME OUT NO PROBLEM AND THAT BY INSERT

  Patient problems: Pain

  MAUDE report 9462666 ↗