MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-19 for MEDPORE UNK manufactured by Medpore.
[350770]
Infected jaw implants.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 502778 |
| MDR Report Key | 502778 |
| Date Received | 2003-12-19 |
| Date of Report | 2003-12-19 |
| Date of Event | 2003-12-12 |
| Date Facility Aware | 2003-12-12 |
| Report Date | 2003-12-19 |
| Date Reported to FDA | 2003-12-19 |
| Date Reported to Mfgr | 2003-12-19 |
| Date Added to Maude | 2003-12-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPORE |
| Generic Name | SILICONE JAW IMPLANTS |
| Product Code | JAZ |
| Date Received | 2003-12-19 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 491551 |
| Manufacturer | MEDPORE |
| Manufacturer Address | 15 DART RD NEWNAN GA 30265 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-12-19 |