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FIREBIRD 44-2101Recalls & reported problems

Orthofix US LLC · Body, Top-Loading · Class 2

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 18257200009718), received between Jul 14, 2017 and Jul 14, 2017 — 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

Device problems

  • Detachment Of Device Component1

Patient problems

  • Fall1
  • Pain1

Recent adverse event reports

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

  • MalfunctionJul 14, 2017Detachment Of Device Component

    INFORMATION PROVIDED STATES THAT PATIENT WITH LUMBAR ARTHRODESIS UNDERWENT SUCCESSFUL SURGERY. TWO WEEKS POST-OP THE PATIENT FELL AND BEGAN EXPERIENCING PAIN. X-RAYS REVEALED THAT THE TOP-LOADING BODY HAD PULLED OFF OF THE PEDICAL SCREW REQUIRING A REVISION SURGERY.

    Patient problems: Fall; Pain

    MAUDE report 6713944 ↗

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-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
  • 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

Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices

All Orthosis, spinal pedicle fixation, for degenerative disc disease devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.