Fortress Pedicular Fixation 64-04-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M7406410017), received between Jul 1, 2024 and Jul 1, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (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

Recent adverse event reports

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

• MalfunctionJul 1, 2024Device Handling Problem; Device Handling Problem

  AN MDR REPORT WAS NOT SUBMITTED WITHIN 30 DAYS OF RECEIVING OR OTHERWISE BECOMING AWARE OF INFORMATION BELOW THAT REASONABLY SUGGESTS THAT A MARKETED DEVICE HAD MALFUNCTIONED AND REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. SPECIFICALLY, BRADSHAW MEDICAL INC. FAILED TO SUBMIT AN MDR REPORT WITHIN 30 DAYS FOR AN EVENT REPORTED TO BRADSHAW MEDICAL WHICH FORTRESS FINAL DRIVER ORTHOPEDIC SURGICAL DEVICE PART NO 64-04-01 FDA A CLASS I DEVICE WAS USED IN SPINE SURGERY WHERE SET SCREW BECAME LOOSE AND REQUIRED A REVISION SURGERY TO TIGHTEN SCREW. THIS IS A BELATED REPORT FOR A MEDICAL DEVICE RELATED EVENT THAT BRADSHAW MEDICAL INC. BECAME AWARE OF ON 16JUN2016 AND IS DOCUMENTED IN COMPANY'S COMPLAINTS (B)(4) (SAME EVENT). AT THE TIME, OUR COMPANY (BRADSHAW MEDICAL INC.) WAS NOT FULLY AWARE OF THE SPECIFIC REQUIREMENTS FOR MDR REPORTING. WE ARE SUBMITTING THIS REPORT NOW TO ENSURE COMPLETE TRANSPARENCY AND COMPLIANCE WITH FDA REGULATIONS. SINCE THIS INCIDENT, WE HAVE IMPLEMENTED PROCEDURES TO ENSURE TIMELY REPORTING OF ALL MDR EVENTS. DURING A 2017 FDA OBSERVATION, IT WAS NOTED THAT A LATE MDR WAS NECESSARY. HOWEVER, DURING FEB 2022 FDA INSPECTION, IT WAS OBSERVED THAT THE MDR WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19650344 ↗