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CrossRoads Screw System 4.0 Headed Implant Prep Kit Including ReamerRecalls & reported problems

Crossroads Extremity Systems · The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device. · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850310006861), received between Sep 29, 2022 and Sep 29, 2022 — classified as 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

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 29, 2022Fracture; Fracture

    REP REPORTS THAT DURING A LAPIDUS PROCEDURE DOCTOR USED 3 SCREWS AND A STAPLE TO PERFORM THE SURGERY. AFTER HE PLACED ONE OF THE 4.0MM SCREWS THE 1.1MM K-WIRE INSTRUMENT BROKE AS HE TRIED TO REMOVE IT FROM THE SCREW. IT HAD TO BE LEFT IN THE PATIENT SINCE IT COULD NOT BE RETRIEVED. REP REPORTS THAT DOCTOR DOES NOT HAVE ANY PLANS TO REVISE THIS PATIENT GOING FORWARD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15501539 ↗

Other Orthopedic Manual Surgical Instrument devices

All Orthopedic Manual Surgical Instrument devices →

Sources and updates

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