MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-11-29 for POREX SURGICAL, INC. UNK manufactured by Porex Surgical.
[381100]
Jaw implant was removed due to infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2004-00003 |
| MDR Report Key | 594723 |
| Report Source | 06 |
| Date Received | 2004-11-29 |
| Date of Event | 2003-12-12 |
| Date Mfgr Received | 2004-01-13 |
| Date Added to Maude | 2005-04-26 |
| 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 | 0 |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal | 30265 |
| Manufacturer Phone | 6784791610 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POREX SURGICAL, INC. |
| Generic Name | POROUS POLYETHYLENE IMPLANT - CHIN/JAW |
| Product Code | JAZ |
| Date Received | 2004-11-29 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 584554 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | * NEWNAN GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-11-29 |