FDA Adverse Event
Malfunction
Summary report: N
ANJON BREMER HALO SYSTEM
MDR report key: 11018784
·
Received December 16, 2020
Report
- Report Number
- 11018784
- Event Type
- Malfunction
- Date Received
- December 16, 2020
- Date of Event
- November 17, 2020
- Report Date
- December 8, 2020
- Manufacturer
- ANJON HOLDINGS LLC
- Product Code
- JEC
- UDI-DI
- 00810592030572
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1481657 | ANJON BREMER HALO SYSTEM | COMPONENT, TRACTION, INVASIVE | JEC | ANJON HOLDINGS LLC | SMALL HALO CROWN STERILE | 170238 | 00810592030572 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |