FALCON™ Anterior Cervical Plate FT10-BP414Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840996115728), received between Sep 1, 2022 and Jan 18, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  DR. (B)(6) PERFORMED A 2-LEVEL ACDF ON A PATIENT ON (B)(6) 2021. IN THIS CASE, HE IMPLANTED ANOTHER COMPANY'S INTERBODY DEVICE WITH THE FALCON PLATE. THE PATIENT CAME IN FOR AN UNSCHEDULED 14-MONTH POSTOPERATIVE FOLLOW-UP VISIT. X-RAYS TAKEN DURING THE 14-MONTH POSTOP VISIT REVEALED THAT ONE OF THE BOTTOM SCREWS COMPLETELY DISLODGED FROM THE FALCON PLATE AND WAS IN SOFT TISSUE. DR. (B)(6) RE-OPERATED ON THE PATIENT AND REMOVED THE DISLODGED SCREW AND LEFT THE REST OF THE HARDWARE UNTOUCHED. DR. (B)(6) RELAYED TO (B)(6) (HIS REP) THAT THERE WERE NO COMPLAINTS FROM THE PATIENT AT THE 12-MONTH VISIT.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 16198191 ↗
• MalfunctionSep 1, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  BOTH SCREWS BROKE BETWEEN (B)(6) 2018 & (B)(6) 2021. WAS REVISED ON (B)(6) 2022. ALL HARDWARE WAS REMOVED WITH EXCEPTION OF BROKEN SCREW TIPS IN BONE.

  Patient problems: Vertebral Fracture

  MAUDE report 15339407 ↗