FlareHawk II-1-0388Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818613020731), received between Mar 23, 2022 and Mar 23, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (1 report).

1 other recall cover devices cleared under the same FDA submission (K160076); 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2022Migration; Migration

  ON 03MAR2022 ACCELUS WAS INFORMED OF A COMPLAINT ON A FLAREHAWK SPLIT SHIM IMPLANT DURING A ONE LEVEL TLIF PROCEDURE ON (B)(6) 2022. IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE THE SURGEON DID NOT CONFIRM LOCKING OF THE IMPLANT INTRAOPERATIVELY AND AS A RESULT THE SHIM MIGRATED POSTOPERATIVELY AND WAS REMOVED VIA AN ADDITIONAL SURGERY ON (B)(6)2022. IT WAS REPORTED THAT DURING THE ORIGINAL PROCEDURE, AFTER DEPLOYMENT THE AUDIBLE CLICK ON THE INSERTER WAS HEARD AND THE SURGEON WAS UNDER THE IMPRESSION THAT THE SHIM WAS LOCKED. IT WAS REPORTED THAT THE SURGEON DID NOT CONFIRM LOCKING VIA A CONTRALATERAL OBLIQUE FLUOROSCOPIC IMAGE AS IS REQUIRED BY THE SURGICAL TECHNIQUE MANUAL. POSTOPERATIVELY, THE PATIENT WAS COMPLAINING OF PAIN AND POSTOPERATIVE IMAGING SHOWED THAT THE SHIM WAS MIGRATING. FURTHER EXAMINATION OF THE INTRAOPERATIVE FLUOROSCOPIC IMAGING CONFIRMED THAT THE SHIM WAS NOT LOCKED IN THE SHELL AT THE TIME OF THE INITIAL PROCEDURE. THE REVISION PROCEDURE WAS PERFORMED WITHOUT COMPLICATION. NO ADDITIONAL PATIENT HARM WAS REPORTED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: Pain

  MAUDE report 13871251 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160076. One submission often covers many models, so check the product and lot details in each record.

• Z-0405-2019 · Feb 27, 2018 · Terminated
  FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with