FlareHawk II-1-0120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850231007107), received between Feb 11, 2018 and Feb 11, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

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 16, 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.

• InjuryFeb 11, 2018Loose or Intermittent Connection; Migration or Expulsion of Device

  IT WAS REPORTED DURING FOLLOW-UP THAT A PATIENT WAS PRESENTING WITH RADICULAR SYMPTOMS. IT WAS DETERMINED (BY THE SURGEON) VIA X-RAY THAT A SHIM HAD MIGRATED POSTERIORLY AND DID NOT APPEAR LOCKED. THE INITIAL PROCEDURE WAS PERFORMED AT L5-S1 AND IT WAS NOTED THAT THE SHIM MAY NOT HAVE BEEN LOCKED. A REVISION WAS ACCOMPLISHED SEVERAL WEEKS LATER IN WHICH THE SURGEON REMOVED THE SHIM AND NOT THE SHELL. THE SHELL WAS LEFT IN THE DISC SPACE AND SURROUNDED AND FILLED WITH BONE GRAFT. THE REMOVED SHIM WAS NOT RETURNED TO THE MANUFACTURER TO REVIEW FOR A DEFECT.

  Patient problems: No Code Available

  MAUDE report 7262610 ↗
• InjuryFeb 11, 2018Difficult or Delayed Positioning; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A FOLLOW-UP, LATERAL X-RAY SHOWED THAT A SHIM APPEARED TO BE PROTRUDING SEVERAL MILLIMETERS POSTERIORLY. IT WAS NOTED THAT DURING THE INITIAL PROCEDURE THE SHIM WAS DIFFICULT TO DELIVER INTO THE SHELL DUE TO POSSIBLE ANATOMICAL CONSTRAINTS AND THE SURGEON CHOSE TO REMOVE THE CONSTRUCT AND USE A SMALLER SIZE. DURING THE REVISION PROCEDURE, THE SHELL AND SHIM WERE REMOVED AND REPLACED WITH A DEVICE FROM ANOTHER MANUFACTURER. THE REMOVED SHELL AND SHIM WERE NOT RETURNED TO THE MANUFACTURER TO REVIEW FOR A DEFECT.

  Patient problems: No Code Available

  MAUDE report 7262604 ↗