Anjon Bremer Halo System Small Halo Crown SterileRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810592030572), received between Dec 16, 2020 and Dec 16, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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.

• MalfunctionDec 16, 2020Unintended Movement

  PATIENT FELT LIKE THE HALO WAS PULLING AND NOT REMAINING IN PLACE. RIGHT FRONT SCREW WAS NO LONGER IN PLACE BUT ABOVE THE PINHOLE AND THE LEFT FRONT SCREW STILL REMAINED IN PLACE HOWEVER IT HAD SLIGHTLY SHIFTED TO THE TOP OF THE PIN HOLE SITE AND WAS PULLING THE SKIN. MANUFACTURER RESPONSE FOR ANJON BREMER HALO SYSTEM CROWN SMALL, ANJON BREMER HALO SYSTEM (PER SITE REPORTER). THEY WILL BE SENDING PACKING MATERIALS FOR SHIPMENT OF THE DEVICE BACK TO THEM. RESPONSIVE AND HELPFUL.

  Patient problems: Insufficient Information

  MAUDE report 11018784 ↗