FDA Adverse Event
Injury
Summary report: N
ENCORE SYSTEM
MDR report key: 20247383
·
Received September 18, 2024
Report
- Report Number
- 3008792120-2024-00010
- Event Type
- Injury
- Date Received
- September 18, 2024
- Date of Event
- December 28, 2021
- Report Date
- December 10, 2024
- Manufacturer
- SIESTA MEDICAL, INC.
- Product Code
- ORY
- PMA / PMN Number
- K213159
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE PATIENT REPORTED THAT THEY HAD A HYOID SUSPENSION YEARS AGO AND THE SUTURE LINES ARE NOT INTACT. ALSO, THE PATIENT WOULD LIKE THE MANDIBULAR SCREW REMOVED, AS THE PATIENT KNICKS HIMSELF WHEN SHAVING.
Description of Event or Problem · 0
THE PATIENT HAD A HYOID SUSPENSION ON (B)(6) 2021. THE SUSPENSION LINES BROKE AND WERE REPLACED IN A REVISION PROCEDURE ON (B)(6) 2021. THIS REVISION PROCEDURE WAS NOT REPORTED TO THE MANUFACTURER UNTIL 10/23/2024. IT WAS REPORTED THAT THE RIGHT SCREW WAS BACKING OUT AND THE PATIENT NICKS HIMSELF WHEN SHAVING. THE DEVICE WAS EXPLANTED ON (B)(6) 2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1235543 | ENCORE SYSTEM | INTRAORAL DEVICE FOR SNORING OR SLEEP APNEA | ORY | SIESTA MEDICAL, INC. | FG0002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |