MAUDE Adverse Event Report: ANJON HOLDINGS LLC ANJON BREMER HALO SYSTEM; COMPONENT, TRACTION, INVASIVE

Model Number	SMALL HALO CROWN STERILE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: ANJON BREMER HALO SYSTEM
• Common Device Name: COMPONENT, TRACTION, INVASIVE
• Manufacturer (Section D): ANJON HOLDINGS LLC; 4801 dawin road; jacksonville FL 32207
• MDR Report Key: 11018784
• Report Number: 11018784
• Device Sequence Number: 19483594
• Product Code: JEC
• UDI-Device Identifier: 00810592030572
• UDI-Public: (01)00810592030572(10)170238(17)230223
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/08/2020
• Report Date (Section F): 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: SMALL HALO CROWN STERILE
• Device Catalogue Number: 100054
• Device Lot Number: 170238
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 12/08/2020