MiniBunion™ MiniBunion Plate, 3.5mm Offset, Short - SterileRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00815432027149), received between Apr 10, 2020 and Dec 11, 2025 — classified as 10 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Migration” (4 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Device Slipped; Device Slipped

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 50 PATIENTS THAT WERE IMPLANTED WITH CROSSROADS MINIBUNION. IMPLANTATION WAS BETWEEN (B)(6) 2019 TO (B)(6) 2024 AT ATLANTIC ORTHOPEDIC SPECIALISTS. SUBJECT ID MB044: 59-YEAR-OLD FEMALE - PATIENT EXPERIENCED IMPLANT LOOSENING AND A MILD INFECTION REQUIRING DEVICE REMOVAL. IMPLANT(S) INVOLVED: PART NUMBER 3100-0030 (1) UNKNOWN 3.0 LOCKING SCREW (1) UNKNOWN 2.7 SCREW (1).

  Patient problems: Unspecified Infection

  MAUDE report 23782027 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 50 PATIENTS THAT WERE IMPLANTED WITH CROSSROADS MINIBUNION. IMPLANTATION WAS BETWEEN (B)(6) 2019 TO (B)(6) 2024 AT ATLANTIC ORTHOPEDIC SPECIALISTS. SUBJECT ID (B)(6): 60-YEAR-OLD FEMALE - PATIENT EXPERIENCED PAIN REQUIRING IMPLANT REMOVAL.

  Patient problems: Pain

  MAUDE report 23781817 ↗
• InjuryDec 11, 2025Migration; Migration

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 50 PATIENTS THAT WERE IMPLANTED WITH CROSSROADS MINIBUNION. IMPLANTATION WAS BETWEEN (B)(6) 2019 TO (B)(6) 2024 AT ATLANTIC ORTHOPEDIC SPECIALISTS. SUBJECT ID (B)(6): 72-YEAR-OLD FEMALE - PATIENT EXPERIENCED HARDWARE MIGRATION REQUIRING REVISION. IMPLANT(S) INVOLVED: PART NUMBER 3100-0030 (1) UNKNOWN 3.0 LOCKING SCREW (1) UNKNOWN 2.7 SCREW (1).

  Patient problems: Insufficient Information

  MAUDE report 23781309 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 50 PATIENTS THAT WERE IMPLANTED WITH CROSSROADS MINIBUNION. IMPLANTATION WAS BETWEEN NOVEMBER 2019 TO FEBRUARY 2024 AT ATLANTIC ORTHOPEDIC SPECIALISTS. SUBJECT ID: (B)(6): 66-YEAR-OLD FEMALE - PATIENT EXPERIENCED INCISION IRRITATION AND INFECTION REQUIRING IMPLANT REMOVAL.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 23780802 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 50 PATIENTS THAT WERE IMPLANTED WITH CROSSROADS MINIBUNION. IMPLANTATION WAS BETWEEN NOVEMBER 2019 TO FEBRUARY 2024 AT ATLANTIC ORTHOPEDIC SPECIALISTS. SUBJECT ID: (B)(6): 18-YEAR-OLD FEMALE - PATIENT EXPERIENCED A SURFICIAL INFECTION. THE PATIENT HAD AN IRRIGATION AND DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 23780057 ↗
• MalfunctionJan 29, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2025 THE DOCTOR HAD A PATIENT WITH A PLATE WHOSE FRAGMENT ROTATED ON DISTAL LOCKING SCREW.

  Patient problems: Insufficient Information

  MAUDE report 21263236 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CAPITAL FRAGMENT IN A MINIBUNION CASE WAS PLATNTER-FLEXED AND NEEDED TO BE REVISED. THERE WAS A REVISION SURGERY PERFORMED ON (B)(4) 2023 DUE TO MALUNION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MINIBUNION PLATE, 3.5MM OFFSET, SHORT ¿ STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 18347953 ↗
• InjuryMay 18, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF IMPLANT PROMINENCE AFTER THE BONE HAD FUSED. IMPLANT WAS REMOVED. SURGEON IS INDICATING THAT IF THE PATIENT HAS A SMALL FOOT, THEM IMPLANT CAN SOMETIME CAUSE DISCOMFORT. THIS REPORT IS FOR ONE (1) MINIBUNION PL, 3.5 MM OFFSET, SHORT STER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Discomfort

  MAUDE report 16955871 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2023, THE SURGEON REPORTED A PLANTARFLEXION OF THE METATARSAL HEAD AFTER A MINIBUNION PROCEDURE. THIS WAS SOMEWHERE BETWEEN 2 AND 6 WEEKS POSTOPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MINIBUNION PLATE, 3.5MM OFFSET, SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Physical Asymmetry

  MAUDE report 16416483 ↗
• InjuryJan 10, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE SURGEON REVISED A MINIBUNION CASE. ON (B)(6) 2022 IT WAS DISCOVERED THAT THE OBLIQUE SCREW WAS BACKING OUT. THE IMPLANT WAS REMOVED AND A MINI-FRAG T-PLATE WAS USED TO FIXATE THE CORRECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MINIBUNION PLATE, 3.5MM OFFSET, SHORT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16132586 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON , THE DR CALLED TO DISCUSS A POSSIBLE REMOVAL OF A MINIBUNION IMPLANT. THE PATIENT IS TO HAVE ANOTHER PROCEDURE AND THE MINIBUNION IMPLANT MAY BE REMOVED. THE REVISION IS NOT DUE TO IMPLANT FAILURE. HOWEVER AFTER LOOKING AT THE X-RAYS, IT APPEARS THE TOE DID NOT HEAL IN A GOOD POSITION. HE WAS ABLE TO COMPLETE THE 2ND PROCEDURE WITHOUT REMOVING THE MINIBUNION IMPLANT. THIS REPORT IS FOR ONE (1) MINIBUNION PLATE, 3.5MM OFFSET, SHORT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 15986557 ↗
• MalfunctionSep 29, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE SURGEON REPORTS REMOVAL OF THE MINIBUNION DEVICE APPROXIMATELY 2 MONTHS POST-OPERATIVELY. THE 19- YEAR-OLD FEMALE INITIAL UNDERWENT THE FOLLOWING DURING THE INITIAL OPERATION ON (B)(6) 2019: 1ST METATARSAL: RIGHT CHEVRON AND AKIN OSTEOTOMY FOR CORRECTION OF HALLUX VALGUS. PLACEMENT OF MINIBUNION: 2ND METATARSAL: CROSSOVER TOE DEFORMITY CORRECTION, 3RD METATARSAL: OSTEOTOMY AND APPLICATION OF UNIPLANAR EXTERNAL FIXATION, 4TH METATARSAL: OSTEOTOMY AND APPLICATION OF UNIPLANAR EXTERNAL FIXATION. THE PATIENT PRESENTED WITH WOUND BREAKDOWN AND HARDWARE EXPOSURE OF THE 3RD AND 4TH METATARSAL UNIPLANAR EXTERNAL FIXATION. THE PATIENT UNDERWENT SURGERY TO REMOVE THE EXTERNAL FIXATION ON (B)(6) 2020. DURING THE SURGERY, THE PLATE AND SCREWS (MINIBUNION) WAS REMOVED. THE SURGEON NOTES THAT THE 1ST METATARSAL WAS WELL HEALED WITH SOLID FIBROUS UNION. NO ADDITIONAL HARDWARE WAS PLACED IN THE 1ST METATARSAL.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 15501555 ↗
• MalfunctionAug 18, 2022Deformation Due to Compressive Stress; Patient Device Interaction Problem

  THE ORIGINAL IMPLANT DATE WAS (B)(6) 2022 FOR THE MINIBUNION PLATES AND SCREWS. ON (B)(6) 2022, REVISION SURGERY OCCURRED. THE REPORTER STATES THAT THE PATIENT FELL OFF A SCOOTER CAUSING THE CAPITAL FRAGMENT TO SHIFT AND MISALIGN. THE SURGEON COMPLETED REVISION SURGERY REPLACING BOTH SCREWS LEAVING THE INITIAL MINIBUNION PLATE.

  Patient problems: Fall

  MAUDE report 15253176 ↗
• MalfunctionMay 5, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  A BUNION CORRECTION WAS REVISED ON (B)(6) 2020 USING THE CROSSROADS MINIBUNION SYSTEM FOR FIXATION OF THE BUNION CORRECTION. THE SURGEON REPORTS THE NON-LOCKING SCREW FAILED. X-RAY EVIDENCE REVEALS THAT THE NON-LOCKING SCREW MISSED THE LATERAL CORTEX OF THE 1ST METATARSAL SHAFT AND WAS FLOATING IN THE OSTEOTOMY SITE INTRAOPERATIVELY. BUNION CORRECTION WAS REVISED ON (B)(6) /2020 USING THE CROSSROADS MINIBUNION SYSTEM FOR FIXATION OF THE BUNION CORRECTION. THE SURGEON REPORTS THE NON-LOCKING SCREW FAILED. X-RAY EVIDENCE REVEALS THAT THE NON-LOCKING SCREW MISSED THE LATERAL CORTEX OF THE 1ST METATARSAL SHAFT AND WAS FLOATING IN THE OSTEOTOMY SITE INTRAOPERATIVELY.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11776380 ↗
• MalfunctionApr 29, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  THE ORIGINAL BUNION CORRECTION WAS PERFORMED ON (B)(6) 2020 WITH THE CROSSROADS MINIBUNION PRODUCTS. X-RAY EVIDENCE AT 2-WEEKS POST-OPERATION SHOWS THE PLATE NOT FULLY SEATED ONTO THE SHAFT OF THE 1ST METATARSAL AND MINIMAL PURCHASE OF THE NON-LOCKING SCREW INTO THE LATERAL CORTEX OF THE SHAFT OF THE 1ST METATARSAL WITH THE SCREW HEAD SLIGHTLY BACKED OUT FROM THE PLATE. ACCORDING TO THE SURGEON, THE PATIENT HAD SEVERE POST-OPERATIVE SWELLING, EVIDENCE OF WOUND BREAKDOWN WITH INFECTION, AND A NON-LOCKING SCREW THAT BACKED-OUT POTENTIALLY FROM RESTLESS LEG SYNDROME.

  Patient problems: Post Operative Wound Infection; Swelling/ Edema

  MAUDE report 11747271 ↗
• MalfunctionApr 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE SURGEON REPORTS REMOVAL OF THE MINIBUNION DEVICE APPROXIMATELY 2 MONTHS POST-OPERATIVELY. THE (B)(6) FEMALE INITIALLY UNDERWENT DOUBLE OSTEOTOMY AND HALLUX VALGUS CORRECTION WITH PLACEMENT OF MINIBUNION FOR HALLUX VALGUS AND A STAPLE AT THE AKIN OSTEOTOMY. ADDITIONALLY, SOFT TISSUE ANCHORS WERE PLACED ACROSS THE DIP AND POP JOINTS OF THE 2ND AND 3RD TOE. THE PATIENT PRESENTED WITH SWELLING, REDNESS, AND SUPERFICIAL DRAINAGE AFTER ORAL ANTIBIOTICS. THE PLATE AND SCREWS (MINIBUNION) WERE REMOVED. THE MOTOCLIP REMAINS IMPLANTED. THE SURGEON NOTES THAT THE 1ST METATARSAL WAS STABLE. NO ADDITIONAL HARDWARE WAS PLACED IN THE 1ST METATARSAL.

  Patient problems: Swelling/ Edema

  MAUDE report 11730323 ↗
• MalfunctionApr 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE DISTRIBUTOR COMMUNICATED THAT THE DOCTOR HAD 3 POTENTIAL INFECTIONS OCCURRED WITH MINIBUNION USAGE. THE SURGEON CONFIRMED THAT ONE OF CASES PERFORMED ON (B)(6) 2020 EXPERIENCED DELAYED HEALING, EDEMA AND TOOK ORAL ANTIBIOTICS. THE SURGEON EXPRESSED THAT DURING THE PROCEDURE CONTROL OF THE CAPITAL FRAGMENT WAS DIFFICULT AND THE BONE CORTEX MAY NOT HAVE BEEN SMOOTH CAUSING SOFT TISSUE IRRITATION AS THERE IS NOT A LOT OF TISSUE OVER THE SURGICAL SITE. THE HARDWARE WAS NOT REMOVED, AND HEALING OCCURRED APPROXIMATELY 6 WEEKS POST-OPERATIVELY.

  Patient problems: Post Operative Wound Infection; Swelling/ Edema

  MAUDE report 11730319 ↗
• MalfunctionSep 19, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT UNDERWENT REMOVAL SURGERY APPROXIMATELY 9 MONTHS AFTER IMPLANTATION DUE TO PROMINENCE DUE TO EXOSTOSIS. THE PATIENT WAS ASYMPTOMATIC PRIOR TO REMOVAL SURGERY. THE PATIENT HAS NO KNOWN ALLERGIES. DURING THE REMOVAL, THE SURGEON OBSERVED BLACK SOFT TISSUE (METALLOSIS) IN THE ENTIRE CANAL AND THE SURFACE OF THE MINIBUNION PLATE. THE IMPLANT WAS REMOVED WITHOUT COMPLICATION.

  Patient problems: Metal Related Pathology

  MAUDE report 10557692 ↗
• MalfunctionAug 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON REMOVED THE METATARSAL HEAD SCREW, REPOSITIONED THE METATARSAL HEAD DUE TO PLANTARFLEXION AND PLACED THE SAME SCREW. THE ORIGINAL IMPLANT WAS PLACED (B)(6) 2020. THE REVISION WAS PERFORMED ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10469764 ↗
• MalfunctionJul 31, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TEN (10) WEEKS POST-OPERATIVE X-RAY SHOW THAT THE JOINT HAS NOT HEALED. THE BUNION CORRECTION INCLUDES A LARGE SHIFT IN A LARGER PATIENT. THE SURGEON STATES THAT THE JOINT TOO MUCH DORSIFLEXION WHICH MAY NOT HEAL.

  Patient problems: No Code Available

  MAUDE report 10353362 ↗
• MalfunctionMay 1, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE SURGEON IMPLANTED A SHORT MINIBUNION PLATE ON (B)(6) 2020. ON (B)(6) 2020, THE IMPLANT WAS REMOVED DUE TO PAIN. AS SHOWN IN X-RAY PRIOR TO REMOVAL, THE DORSAL FLEXION ANGLE IS 43.9 DEGREE AND CAUSING PAIN FOR THE PATIENT. MINIBUNION WAS REMOVED AND REPLACED WITH MINI FRAGMENT PLATE AND SCREWS. NO BREAK OF THE MINIBUNION SCREWS OR PLATES WERE OBSERVED.

  Patient problems: No Code Available

  MAUDE report 10017943 ↗
• MalfunctionApr 10, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  APPROXIMATELY, 2 WEEKS AFTER THE INITIAL SURGERY, THE PATIENT FELL AND LANDED WITH HER FULL WEIGHT ON THE FOOT WITH MINIBUNION SYSTEM. AN X-RAY AFTER THE FALL WAS PROVIDED SHOWING SIGNIFICANT SWELLING. THE PATIENT WAS EXPERIENCING PAIN; THEREFORE, THE SURGEON REMOVED THE IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9948454 ↗