FDA Adverse Event
Injury
Summary report: N
ENCORE SYSTEM
MDR report key: 10533019
·
Received September 14, 2020
Report
- Report Number
- 3008792120-2020-00002
- Event Type
- Injury
- Date Received
- September 14, 2020
- Date of Event
- August 17, 2020
- Report Date
- September 10, 2020
- Manufacturer
- SIESTA MEDICAL, INC.
- Product Code
- ORY
- PMA / PMN Number
- K183310
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 1
ON AUGUST 17, 2020, THE PHYSICIAN REPORTED TO SIESTA MEDICAL THAT A PATIENT WHO HAD PREVIOUSLY HAD A HYOID SUSPENSION ON (B)(6) 2020, HEARD A "POP" ON THE RIGHT SIDE OF THE SUSPENSION AND WAS IN PAIN. ON (B)(6) 2020, AN X-RAY SHOWED THE BONE SCREW ON THE RIGHT SIDE WAS DISLODGED FROM THE MANDIBLE. THE PHYSICIAN PERFORMED AN EXPLORATION AND REPORTED THAT IT APPEARED THE PILOT HOLE WAS TOO LARGE TO SECURE THE BONE SCREW. THE PHYSICIAN DRILLED ANOTHER PILOT HOLE, THE BONE SCREW WAS REATTACHED , AND THE HYOID BONE WAS RESUSPENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 991245 | ENCORE SYSTEM | TONGUE/HYOID SUSPENSION | ORY | SIESTA MEDICAL, INC. | FG0002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |