MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-03-01 for ECLIPSE PISTON 472-450 manufactured by Grace Medical, Inc..
[137593596]
The loop was found to be opened and twisted upon receipt. This indicated that the loop was opened, as if removed from the incus. Heat was applied to the opened loop and it closed meeting specifications. Following the closure, the loop did not re-open.
Patient Sequence No: 1, Text Type: N, H10
[137593597]
It was reported that this device was explanted during a revision surgery, as the loop of the stapes prosthesis was found to be in the opened position and lying in the middle ear space.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000022662-2019-00001 |
| MDR Report Key | 8383243 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-03-01 |
| Date of Report | 2019-02-13 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2017-06-06 |
| Date Added to Maude | 2019-03-01 |
| 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 | MS. CARLYN REYNOLDS |
| Manufacturer Street | 8500 WOLF LAKE DRIVE SUITE 110 |
| Manufacturer City | MEMPHIS TN 381334104 |
| Manufacturer Country | US |
| Manufacturer Postal | 381334104 |
| Manufacturer Phone | 9013860990 |
| Manufacturer G1 | GRACE MEDICAL, INC. |
| Manufacturer Street | 8500 WOLF LAKE DRIVE SUITE 110 |
| Manufacturer City | MEMPHIS TN 381334104 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 381334104 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECLIPSE PISTON |
| Generic Name | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT |
| Product Code | ETB |
| Date Received | 2019-03-01 |
| Returned To Mfg | 2019-02-14 |
| Catalog Number | 472-450 |
| Lot Number | 56704 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRACE MEDICAL, INC. |
| Manufacturer Address | 8500 WOLF LAKE DRIVE SUITE 110 MEMPHIS TN 381334104 US 381334104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-01 |