FIREBIRD 44-2001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18257200009695), received between Sep 4, 2015 and Mar 8, 2016 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2016Migration or Expulsion of Device

  INFORMATION PROVIDED STATES THAT DOCTOR PERFORMED PL FUSION FROM T10-L2 ON (B)(6) 2015. DURING FOLLOW UP VISIT IT WAS NOTICED THAT THREE SET SCREWS, (2) AT L2 AND (1) AT L3, HAD BACKED OUT OF THE CONSTRUCT ALLOWING THE RODS OUT OF THE TULIPS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO REMOVE AND REPLACE 10 SET SCREWS.

  Patient problems: No Code Available

  MAUDE report 5486788 ↗
• MalfunctionSep 4, 2015Device Dislodged or Dislocated

  INFORMATION PROVIDED STATES THAT THE PATIENT HAD SURGERY AT L5-S1 ON (B)(6) 2015. THE PATIENT FELL THREE MONTHS POST-OP. X-RAYS TAKEN SHOW THAT TWO OF THE SET SCREWS HAD BECOME DISLODGED FROM HARDWARE ON RIGHT AND LEFT SIDE AT L5. REVISION SURGERY TOOK PLACE ON (B)(6) 2015 TO REMOVE AND REPLACE TWO SET SCREWS. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: Fall

  MAUDE report 5058397 ↗
• MalfunctionSep 4, 2015Device Dislodged or Dislocated

  INFORMATION PROVIDED STATES THAT THE PATIENT HAD SURGERY AT L4-L5 ON (B)(6) 2015. THE PATIENT FELL ON (B)(6) 2015. XSET -RAYS TAKEN ON (B)(6) 2015 SHOWED THAT THE LEFT L4 PEDICLE SCREW HAD COME OUT OF THE HARDWARE. REVISION SURGERY TOOK PLACE ON (B)(6) 2015 TO REMOVE AND REPLACE THE LOOSE SCREW. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: Fall

  MAUDE report 5056731 ↗

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