Minimally Invasive Bunion Plate, Right 300-70-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00812926027708), received between Jan 30, 2020 and Aug 30, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021, AN INDEPENDENT SALES REPRESENTATIVE CONTACTED THE DJO FOOT & ANKLE SALES SUPPORT MANAGER TO REQUEST A MINIMALLY INVASIVE BUNION (MIB) REMOVAL KIT FOR THE REMOVAL OF AN MIB CONSTRUCT DUE TO REPORTED PATIENT PAIN. THE REMOVAL IS SCHEDULED FOR (B)(6) 2021 AT FACILITY 1 BY DOCTOR 1. THE MIB CONSTRUCT WAS ORIGINALLY IMPLANTED BY DOCTOR 1. THE ABOVE DETAILS ARE ALL THIS IS KNOWN FOR THE REPORT AT THIS TIME AND A FOLLOW UP WILL OCCUR WITH THE SALES REPRESENTATIVE POST-REMOVAL.

  Patient problems: Pain

  MAUDE report 12388209 ↗
• InjuryMay 5, 2021Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  ON 04/07/2021, A TRILLIANT SURGICAL INDEPENDENT SALES REPRESENTATIVE CALLED A TRILLIANT SURGICAL SALES SUPPORT SPECIALIST REPORTING OF A MINIMALLY INVASIVE BUNION (MIB) CONSTRUCT AND HAMMER TOE IMPLANT REMOVAL AT HOSPITAL 1 WITH DOCTOR 1, THAT OCCURRED ON (B)(6) 2021 ON A FEMALE PATIENT. THE ORIGINAL IMPLANTATION OCCURRED ON (B)(6) 2019 , ALSO AT HOSPITAL 1 WITH DOCTOR 1. THE PATIENT CAME IN POST-OPERATIVELY REPORTING OF LOCALIZED PAIN AND IRRITATION AT THE SURGICAL SITE. THE 2ND METATARSAL ALSO WAS OBSERVED TO HAVE A RECURRENT HAMMERTOE. UPON REVIEW OF INITIAL X-RAY, THE SALES REPRESENTATIVE STATED THAT THE MIB CONSTRUCT "SEEMED BROAD" AND THAT THE 200-24-028 (2.4MM X 28MM TIGER CANNULATED SCREW) SEEMED TO BE BACKING OUT AS WELL AS THE GRIDLOCK LOCKING SCREW (LENGTH UNKNOWN AT THIS POINT IN THE INVESTIGATION). THE SALES REPRESENTATIVE ALSO STATED THAT FUSION HAD NOT OCCURRED IN THE 2ND METATARSAL. DOCTOR 1 OPTED TO REMOVE THE ENTIRE MIB CONSTRUCT AND THE 204-30-008 (3.4 X 3.0 X 8MM HAMMERTOE IMPLANT) AT THE SCHEDULED REMOVAL ON (B)(6) 2021 . TO CORRECT THE BUNION, A 500-10-101 (10MM X 10MM X 10MM STAPLE) WAS IMPLANTED. TO CORRECT THE HAMMERTOE DEFORMITY IN THE 2ND METATARSAL, A LO

  Patient problems: Deformity/ Disfigurement; Nonunion/Delayed-union Bone Fracture; Pain; Skin Inflammation/ Irritation

  MAUDE report 11776427 ↗
• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, DOCTOR 1 CALLED IN TO TRILLIANT SURGICAL REQUESTING A MINIMALLY INVASIVE BUNION (MIB) PLATE REMOVAL KIT FOR AN UPCOMING REMOVAL SCHEDULED ON (B)(6) 2020. A TRILLIANT SURGICAL SALES SUPPORT SPECIALIST INQUIRED ABOUT THE NATURE OF THE REMOVAL WITH DOCTOR 1 ON THE SAME PHONE CALL AND THE FOLLOWING DETAILS WERE CAPTURED INITIALLY. DOCTOR 1 REPORTED THAT THE 300-70-001 (MINIMALLY INVASIVE BUNION PLATE, RIGHT) SHALL BE REMOVED DUE TO THE PATIENT ((B)(6)-YEAR-OLD FEMALE) REPORTING PAIN AT THE HARDWARE SITE AND THAT THE INCISION WAS NOT HEALING PROPERLY. DOCTOR 1 REPORTED THAT HE WAS NOT AWARE OF ANY PREVIOUS NONCOMPLIANCE WITH THE PATIENT TO INFLUENCE ANY OF THESE RESULTS. THE PLATE CONSTRUCT WAS ORIGINALLY IMPLANTED ON (B)(6) 2019 WITH DOCTOR 2 AT FACILITY X (INVOICE (B)(6)). IT IS TO BE NOTED THAT DOCTOR 2 UTILIZED A 202-24-030 (2.4 X 30MM TIGER HEADLESS SCREW) AS THE LAG SCREW IN THE BUNION CORRECTION IN THE ORIGINAL IMPLANTATION. THE LOCAL REPRESENTATIVE HAS BEEN SHIPPED ALL NECESSARY REMOVAL TOOLS AND WILL BE PRESENT AT THE REMOVAL CASE AND IT IS EXPECTED THAT ALL PARTS SHALL BE RETURNED TO CORPORATE FOR REVIEW. FURTHER DETAILS TO FOLLOW AT CONCLUSION OF REMOVAL ON (B

  Patient problems: Irritation; Pain

  MAUDE report 10428594 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  06/23/2020 DESCRIPTION OF INCIDENT / EVENT: A TRILLIANT SURGICAL SALES REPRESENTATIVE REPORTED THAT DOCTOR 1 TEXTED HIM INQUIRING WHO HE NEEDED TO SPEAK TO IN REGARDS TO REMOVING AN IMPLANTED MINIMALLY INVASIVE BUNION (MIB) CONSTRUCT. THE CONSTRUCT WAS ORIGINALLY IMPLANTED ON (B)(6) 2018 AT FACILITY 1 BY DOCTOR 1. THE PATIENT AT THE TIME OF IMPLANTATION WAS (B)(6), NOW (B)(6)-YEAR-OLD FEMALE. AT THIS TIME, IT'S NOT YET KNOWN AS TO WHY THE CONSTRUCT IS BEING REMOVED. A CONFERENCE CALL IS SCHEDULED WITH DOCTOR 1 FOR 06/25/2020 AT 9:30AM CST BETWEEN A TRILLIANT SURGICAL ENGINEERING REPRESENTATIVE, SALES SUPPORT REPRESENTATIVE, AND PRODUCT MANAGER REPRESENTATIVE TO ASSIST IN DOCTOR 1'S REQUEST REGARDING REMOVAL AND TO OBTAIN MORE INFORMATION. 07/09/2020 ADDITIONAL INFORMATION: THE SALES REPRESENTATIVE REPORTED THAT DOCTOR 1 SUCCESSFULLY REMOVED ALL MIB HARDWARE, ORIGINALLY IMPLANTED ON (B)(6) 2018, ON (B)(6) 2020 AS PLANNED. THE PATIENT EXPERIENCED AND REPORTED PAIN IN (B)(6) 2020. DOCTOR 1 PERFORMED AN INCISION AND DRAINAGE (I/D) IN-OFFICE SEVERAL WEEKS BEFORE THE REMOVAL OF HARDWARE DUE TO SWELLING AND INFECTION. HE DOES NOT KNOW THE ROOT CAUSE OF THE INFECTION AT THIS TIME. THE SALE

  Patient problems: Pain; Post Operative Wound Infection

  MAUDE report 10304779 ↗
• InjuryFeb 7, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A DOCTOR PERFORMED A BUNIONECTOMY ON A FEMALE PATIENT. THE ORIGINAL DATE OF IMPLANTATION IS BELIEVED TO BE (B)(6) 2019. A TRILLIANT SURGICAL SALES REPRESENTATIVE EMAILED A SCREENSHOT OF A MESSAGE TO SALES SUPPORT FROM THE AFOREMENTIONED DOCTOR STATING THE FOLLOWING, "ANOTHER PATIENT THAT PLATE HAS TO BE REMOVED. SKIN MARKER IS WHERE SHE BASICALLY HAS A PRESSURE ULCER FROM HER SHOES. NOT Y'ALLS FAULT BUT EXTREMELY UNHAPPY WITH HOW THESE HAVE TURNED OUT. I FEEL TERRIBLE FOR THE PATIENT. HOPEFULLY SHE DOES NOT HAVE A HIGH DEDUCTIBLE AND WE CAN TAKE CARE OF THIS SOON. I WON'T BE USING THIS PRODUCT IN 2020." THE TRILLIANT SURGICAL SALES REPRESENTATIVE BELIEVES FUSION HAD OCCURRED AND NOTES THAT THE PATIENT IS VERY SMALL AND THE MIB PLATE AND SCREWS SEEM TO BE TOO PROUD BECAUSE THE MIB CONSTRUCT CAN BE EASILY FELT. THE REMOVAL CASE WAS REPORTED TO OCCUR ON (B)(6) 2020.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 9682124 ↗
• InjuryJan 30, 2020Migration; Migration

  A SURGEON PERFORMED A BUNIONECTOMY ON A (B)(6) FEMALE PATIENT ON (B)(6) 2019 UTILIZING THE MINIMALLY INVASIVE BUNION PLATING SYSTEM. ACCORDING TO THE TRILLIANT SALES REPRESENTATIVE, A 2.4MM GRIDLOCK NON-LOCKING SCREW WAS BACKING OUT OF THE SURGICAL SITE AND WAS REMOVED ON (B)(6) 2019 IN THE SURGEON'S OFFICE. THIS EVENT IS DISCUSSED WITHIN MDR REPORT #3007420745-2020-00009. THE TRILLIANT SALES REPRESENTATIVE WAS INFORMED ON DECEMBER 18, 2019 THAT THE SURGEON WAS REQUESTING REMOVAL INSTRUMENTS IN ORDER TO TAKE OUT THE PLATE AND REMAINING SCREWS. THE TRILLIANT SALES REPRESENTATIVE NOTED THAT "IT WAS REMOVED BECAUSE IT WAS TOO PROUD (PATIENT COULD EASILY PALPATE PLATE AND INITIAL SCREW THAT WAS REMOVED)." THE 300-70-001 RIGHT MIB PLATE AND ASSOCIATED SCREWS (200-24-018, 301-24-020, AND 302-24-024) WERE REMOVED ON (B)(6) 2019. THE TRILLIANT SALES REPRESENTATIVE CONFIRMED THAT FUSION HAD OCCURRED. BOTH EVENTS MENTIONED ABOVE ARE CAPTURED AS PART OF (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9650186 ↗