N/A ASY-00133Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810004721890), received between Jan 10, 2025 and Jan 10, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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.

• InjuryJan 10, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6), ACCELUS WAS MADE AWARE OF AN EVENT WHEN DR. (B)(6) INFORMED US THAT THEY WERE NEEDING TO PERFORM SURGICAL INTERVENTION FROM A CASE ON (B)(6)2024. THE PATIENT HAD A TLIF USING FLAREHAWK7. THE SURGEON SAID THEY WERE NEEDING TO REVISE THE CASE DUE TO L5 PARESIS. HE SAID THAT BONE CHIPS WERE BLOCKING THE FORAMEN. HE REPORTED HAVING TROUBLE WITH THE BONE FUNNEL BECAUSE THE BONE GRAFT HAD BIG CHUNKS SO THEY GOT STUCK IN THE FH7 BONE FUNNEL. THUS, THE COMPLAINT IS ALLEGING AN ISSUE WITH GRAFT DELIVERY THROUGH THE TAMP AND FUNNEL AND THERE WAS NO ALLEGED ISSUE WITH THE IMPLANTS FROM THE CASE. ON (B)(6), ADDITIONAL INFORMATION WAS PROVIDED AFTER SPEAKING WITH DR. (B)(6), HE REPORTED THAT THE PATIENT'S REVISION WENT FINE AND THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS ABLE TO BE PROVIDED FOR THE DEVICES INVOLVED. AT THE REVISION, THEY TOOK ALL THE BONE GRAFT THAT WAS MISPLACED. PATIENT HAD MUCH BETTER CONTROL YESTERDAY BUT STILL WITH NUMBNESS IN A TOLERABLE RADICULAR PAIN (IN REGRESSION).

  Patient problems: Numbness; Paresis

  MAUDE report 21123962 ↗