FIREBIRD 77-8645Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18257200114566), received between Mar 25, 2016 and Mar 25, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K081684); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 25, 2016Detachment Of Device Component

  BASED ON THE INFORMATION PROVIDED, TWO (2) WEEKS POST-OP THE PATIENT FELL AND THE HEAD OF THE SCREW DISASSOCIATED FROM THE SCREW. THE REVISION SURGERY WAS PERFORMED TO REMOVE THE DEVICE.

  Patient problems: Fall

  MAUDE report 5525238 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081684. One submission often covers many models, so check the product and lot details in each record.

• Z-0855-2014 · Nov 26, 2013 · Terminated
  Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedic
• Z-1674-2011 · Oct 22, 2010 · Terminated
  BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Mul
• Z-1608-2011 · Oct 22, 2010 · Terminated
  ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. Intended for use in conjunction with Multi-Axial Reduction S