MiniBunionRecalls & reported problems across all models
Crossroads Extremity Systems · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 7 models of MiniBunion by Crossroads Extremity Systems in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2019 and Dec 11, 2025 — classified as 13 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Migration” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MiniBunion problems
Device problems
- Appropriate Device Problem Term/Code Not Available8
- Migration7
- Adverse Event Without Identified Device or Use Problem6
- Device-Device Incompatibility6
- Patient Device Interaction Problem3
- Fracture2
- Defective Device1
- Deformation Due to Compressive Stress1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Code Available4
- Failure of Implant3
- Malunion of Bone3
- Swelling/ Edema3
- Unspecified Infection3
- Insufficient Information2
- Post Operative Wound Infection2
MiniBunion models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MiniBunion™ MiniBunion Plate, 3.5mm Offset, Short - SterilePlate, Fixation, Bone22 reports
- MiniBunion™ MinBunion Capital Fragment Guide Kit - SterileGuide, Surgical, Instrument4 reports
- MiniBunion™ MiniBunion, Non-Locking Screw, 2.7mm x 14mm - SterilePlate, Fixation, Bone2 reports
- MiniBunion™ MiniBunion, Non-Locking Screw, 2.7mm x 16mm - SterilePlate, Fixation, Bone2 reports
- MiniBunion™ MiniBunion Plate, 4.5mm Offset, Long - SterilePlate, Fixation, Bone2 reports
- 1 report
- MiniBunion™ MiniBunion, Polyaxial Locking Screw, 3mm x 22mm - SterilePlate, Fixation, Bone1 report
Recent MiniBunion adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionSep 8, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING INSPECTION; THE DEVICE WOULDN'T THREAD. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22994980 ↗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 ↗MalfunctionJan 11, 2024Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility
IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE 1.6MM K-WIRES THAT ARE SUPPOSED TO FIT IN THE MINIBUNION CAPITAL FRAGMENT GUIDE WOULD NOT FIT IN THE HOLES. THE STAFF TRIED TO USE SMALLER WIRES, BUT THOSE WERE NOT RIGID ENOUGH TO BE USED IN THE CASE. THEY CONTINUED THE CASE, AND THE PATIENT OUTCOME WAS NOT AFFECTED. THIS REPORT INVOLVES ONE MINIBUNION CAPITAL FRAG CTRL GUIDE STER. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18490877 ↗MalfunctionJan 3, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SURGEON WAS PERFORMING A MINI-BUNION PROCEDURE ON (B)(6) 2023, AT APPROXIMATELY 8AM. SALES REP WAS COVERING THE CASE. WHILE ATTEMPTING TO UTILIZE THE CAPITAL FRAGMENT CONTROL GUIDE (AKA: VIKING SHIP) DR WAS UNABLE TO GET THE SUPPLIED 1.6MM K-WIRES INTO ANY OF THE HOLES. SMALLER K-WIRES WERE UTILIZED THAT FIT INTO THE HOLES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) MINIBUNION CAPITAL FRAG CTRL GUIDE STER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18434180 ↗MalfunctionDec 20, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE HOLES IN THE CAPITAL FRAGMENT CONTROL GUIDE WERE FOUND TO BE TOO SMALL FOR THE PINS PROVIDED. THIS SAME ISSUE WAS FOUND ON BOTH GUIDE KITS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A SMALLER WIRE TO PASS THROUGH THE CAPITAL FRAGMENT GUIDE. THIS REPORT IS FOR A MINIBUNION DRILL KIT ¿ STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18363796 ↗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 ↗MalfunctionDec 14, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE HOLES IN THE CAPITAL FRAGMENT CONTROL GUIDE WERE FOUND TO BE TOO SMALL FOR THE PINS PROVIDED. THIS SAME ISSUE WAS FOUND ON BOTH IPS IN QUESTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A SMALLER WIRE TO PASS THROUGH THE CAPITAL FRAGMENT GUIDE. THIS REPORT IS FOR A MINIBUNION CAPITAL FRAGMENT GUIDE KIT ¿ STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18326516 ↗MalfunctionDec 14, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE HOLES IN THE CAPITAL FRAGMENT CONTROL GUIDE WERE FOUND TO BE TOO SMALL FOR THE PINS PROVIDED. THIS SAME ISSUE WAS FOUND ON BOTH IPS IN QUESTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A SMALLER WIRE TO PASS THROUGH THE CAPITAL FRAGMENT GUIDE. THIS REPORT IS FOR A MINIBUNION CAPITAL FRAGMENT GUIDE KIT ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18326509 ↗InjuryMay 24, 2023Migration; Migration
IT WAS REPORTED THAT ON (B)(6)2023, THE OBLIQUE NON-LOCKING SCREW BACKED OUT. SURGEON REMOVED THE OBLIQUE SCREW. BUNION CORRECTION IS GOOD. THIS REPORT IS FOR ONE (1) MINIBUNION NONLCKNG SCR 2.7MMX14MM STER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Failure of Implant
MAUDE report 16991960 ↗InjuryMay 24, 2023Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY TO IMPLANT THE MINIBUNION IMPLANTS. ON (B)(6) 2023, THE OBLIQUE NON-LOCKING SCREW BACKED OUT POSTOPERATIVELY, REQUIRING A SURGERY TO REMOVE THE SCREW. BUNION CORRECTION WAS GOOD. THE IMPLANT HAD BEEN IN THE PATIENT FOR GREATER THAN 12 MONTHS. THIS REPORT INVOLVES ONE MINIBUNION, NON-LOCKING SCREW, 2.7MM X 14MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 16991247 ↗
Other Crossroads Extremity Systems products
All Crossroads Extremity Systems devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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