Minimally Invasive Bunion Plate, Left 300-70-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812926027715), received between Dec 13, 2019 and Feb 19, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 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.

• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, A TRILLIANT SURGICAL INDEPENDENT SALES REPRESENTATIVE REPORTED THAT DURING A POST-OPERATIVE REVIEW, DOCTOR 1 HAD A PATIENT REPORT OF PAIN AT THE SURGICAL SITE OF A PREVIOUSLY IMPLANTED 300-70-002 (MINIMALLY INVASIVE BUNION PLATE, LEFT) (ORIGINAL IMPLANTATION: (B)(6) 2020, PATIENT DETAILS ARE CURRENTLY UNKNOWN). DOCTOR 1 SAW THE PLATE HAD SHIFTED AND WASN'T ACHIEVING OPTIMAL COMPRESSION. A REMOVAL WAS SCHEDULED FOR (B)(6) 2021 AND FURTHER DETAILS REGARDING PATIENT NON-COMPLIANCE AND REMOVAL DETAILS WILL BE OBTAINED FROM THE SALES REPRESENTATIVE UPON COMPLETION OF SURGERY. ALL FURTHER DETAILS OBTAINED SHALL BE DOCUMENTED AFTER THE SCHEDULED REMOVAL. ADDITIONAL INFORMATION OBTAINED 01/22/2021: ON 01/22/2021, A TRILLIANT SURGICAL SALES SUPPORT SPECIALIST INTERVIEWED THE SALES REPRESENTATIVE IN REGARDS TO THE REMOVAL CASE ON (B)(6) 2021 WITH DOCTOR 1 AT FACILITY 1. DOCTOR 1 STATED THAT THE PATIENT WAS EXPERIENCING LOCALIZED PAIN AT THE SURGICAL SITE AND INTENDED ON REMOVING THE FULL CONSTRUCT. HOWEVER, UPON REVIEW, DOCTOR 1 NOTICED FUSION HAD OCCURRED AND THAT THERE WAS A SMALL FRAGMENT OF BONE DISLODGED AT THE SURGICAL SITE CAUSING THE IRRITATION AND REDNESS WHERE THE P

  Patient problems: Pain

  MAUDE report 11349061 ↗
• InjuryJun 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, A TRILLIANT SURGICAL SALES REPRESENTATIVE REPORTED OF A MINIMALLY INVASIVE BUNION (MIB) PLATE, LEFT (300-70-002) REMOVAL AT FACILITY 2 WITH DOCTOR 2 ON A (B)(6) YEAR-OLD FEMALE PATIENT ON (B)(6) 2020. THE ORIGINAL IMPLANTATION OF THE 300-70-002 WAS AT FACILITY 1 ON (B)(6) 2020 WITH DOCTOR 1. DOCTOR 1 WAS UNAVAILABLE TO REMOVE THE PLATE AND DESIGNATED HIS COLLEAGUE (DOCTOR 2) TO PERFORM THE REMOVAL. DOCTOR 2 REMOVED THE 300-70-002 AND ASSOCIATED SCREWS (200-24-020 - 2.4MM X 20MM TIGER CANNULATED SCREW, 200-24-026 - 2.4 X 26MM TIGER CANNULATED SCREW, AND 302-24-018 - 2.4 X 18MM GL LOCKING SCREW) FROM THE PATIENT BECAUSE THE SITE HAD DEHISCED AND BONE WAS EXPOSED. DOCTOR 2 REPORTED THAT THE PATIENT WAS PREVIOUSLY IN A WALKING BOOT AND THE BOOT WAS CAUSING FRICTION ON THE PATIENT'S SURGICAL SITE. DOCTOR 2 OPTED TO UTILIZE THE A COMPETITOR'S SYSTEM TO CORRECT THE BUNION. THE SALES REPRESENTATIVE WAS PRESENT AT BOTH THE IMPLANTATION AND THE REMOVAL AND WILL BE ABLE TO RETURN THE 300-70-002 AND ASSOCIATED SCREWS FOR REVIEW.

  Patient problems: Wound Dehiscence

  MAUDE report 10114233 ↗
• InjuryDec 13, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2019, (B)(6), OUR TRILLIANT SALES REPRESENTATIVE, CALLED SALES SUPPORT TO REPORT THAT AN MIB PLATE AND ASSOCIATED SCREWS WERE REMOVED ON (B)(6) 2019 AT (B)(6). DR. (B)(6) ORIGINALLY PERFORMED THE BUNIONECTOMY ON A (B)(6) FEMALE ON (B)(6)2019 UTILIZING (B)(6) PERSONAL MINIMALLY INVASIVE BUNION PLATING SYSTEM. THE PATIENT CAME IN FOR A REGULAR POST-OP APPOINTMENT WITH REPORT OF PAIN. (B)(6) CONFIRMED THAT FUSION OCCURRED. THE REMOVED HARDWARE WAS RETAINED BY THE PATIENT AND WILL NOT BE RETURNED TO CORPORATE FOR REVIEW.

  Patient problems: Pain

  MAUDE report 9470382 ↗