MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-15 for ENCORE SYSTEM FG0002 manufactured by Siesta Medical Inc..
[108806658]
The device was not returned to siesta medical, therefore unable to determine a definitive cause of the event. Although the cause of the failure of the device is unknown, this mdr is being filed for notification purposes. No conclusions can be drawn at this time. Should additional information be obtained, a supplemental form will be filed.
Patient Sequence No: 1, Text Type: N, H10
[108806659]
On (b)(6) 2018, 4 weeks post hyoid suspension surgery, patient reported to physician that he heard a "pop". The physician believed that this was due to suture breakage but no investigation was reported at the time to confirm. On (b)(6) 2018 the physician reported tha the patient had some recurrence of his sleep apnea. On (b)(6) 2018, the physician performed exploratory surgery to determine if the suspension suture had indeed broken. During the surgery and upon dissection down to the hyoid bone, he observed that both suspension lines (sutures) had broken. It was no clear what caused the sutures to break. The physician then revised the hyoid suspension by replacing both bone screws, insuring that the eyelets were properly oriented and suspending the hyoid bone using arthrex fiberwire #2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008792120-2018-00001 |
| MDR Report Key | 7515777 |
| Date Received | 2018-05-15 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-05-11 |
| Date Mfgr Received | 2018-05-11 |
| Date Added to Maude | 2018-05-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TEDD HINTON |
| Manufacturer Street | 101 CHURCH STREET SUITE 3 |
| Manufacturer City | LOS GATOS CA 95030 |
| Manufacturer Country | US |
| Manufacturer Postal | 95030 |
| Manufacturer Phone | 4085963148 |
| Manufacturer G1 | SIESTA MEDICAL INC. |
| Manufacturer Street | 101 CHURCH STREET SUITE 3 |
| Manufacturer City | LOS GATOS CA 95030 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENCORE SYSTEM |
| Generic Name | TONGUE/HYOID SUSPENSION |
| Product Code | ORY |
| Date Received | 2018-05-15 |
| Model Number | FG0002 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIESTA MEDICAL INC. |
| Manufacturer Address | 101 CHURCH STREET SUITE 3 LOS GATOS CA 95030 US 95030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-15 |