MiniBunion™ MiniBunion, Non-Locking Screw, 2.7mm x 16mm - SterileRecalls & reported problems
Crossroads Extremity Systems · The MiniBunion™ Implant System is indicated for stabilization and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of an intramedullary implant and screws. · Class 2 · Implant
All models of MiniBunion (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815432027026), received between Dec 12, 2019 and Sep 29, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
Patient problems
- Missing Value Reason1
- No Clinical Signs, Symptoms or Conditions1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2022Fracture; Fracture
DOCTOR PERFORMED A MINIBUNION SURGERY ON (B)(6) 2019. AT 13 WEEKS POST-OPERATION DURING A FOLLOW-UP VISIT ON (B)(6) 2019, AN X-RAY REVEALED A BROKEN NON-LOCKING SCREW IN A MINIBUNION PLATE. THERE IS NO RESOLUTION TO DATE FOR THIS CASE. DOCTOR REPORTS THAT THE PATIENT IS DOING FINE, AND HE HAS NO PLANS TO REVISE THIS PATIENT OR REMOVE HARDWARE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15501697 ↗InjuryDec 12, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE DOCTOR PERFORMED A MINIBUNION SURGERY ON (B)(6) 2019. AT 2ND WEEK FOLLOW-UP THE PATIENT WAS WALKING, AND THE INCISION OPENED UP RESULTING IN WOUND ISSUES. THE DOCTOR WASHED THE INCISION ON (B)(6) 2019 AND TIGHTENED THE NON-LOCKING SCREW. THE SHAFT WAS PACKED WITH CANCELLOUS BONE CHIPS. THE PATIENT WAS HOSPITALIZED FOR 7 DAYS. INTRAVENOUS ANTIBIOTICS WERE GIVEN FOR 2 WEEKS AND ORAL ANTIBIOTICS FOR AN ADDITIONAL 2 WEEKS. NO EVIDENCE OF A BONE INFECTION WAS IDENTIFIED.
Patient problems: Missing Value Reason; Patient Problem/Medical Problem
MAUDE report 9460299 ↗
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- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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