MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-23 for DORNHOFFER INTERPOSITIONAL PORP 70141014 manufactured by Gyrus Acmi, Inc..
[55471837]
Patient Sequence No: 1, Text Type: N, H10
[55471838]
The surgeon asked for a middle ear implant dornhoffer interpositional/porp w/titanium cradle, 3mm overall length 2mm functional length dense ha/titanium 3. 2mm head. The outer box was completely sealed as well as the sterile inner package. There was no evidence of a break in sterile packaging. When the surgeon opened the sterile plastic tray lid in the operative field, a piece of bloody tissue was present along with the implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5972765 |
| MDR Report Key | 5972765 |
| Date Received | 2016-09-23 |
| Date of Report | 2016-09-02 |
| Date of Event | 2016-08-22 |
| Report Date | 2016-09-02 |
| Date Reported to FDA | 2016-09-02 |
| Date Reported to Mfgr | 2016-09-02 |
| Date Added to Maude | 2016-09-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNHOFFER INTERPOSITIONAL PORP |
| Generic Name | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT |
| Product Code | ETB |
| Date Received | 2016-09-23 |
| Model Number | 70141014 |
| Lot Number | 0732302453 |
| Device Expiration Date | 2017-08-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-23 |