MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-01-25 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[1412833]
The doctor stated that the patient received a medpor mandible implant. The doctor stated that he placed the implant using the intraoral route. The doctor reported that the patient developed an infection. The doctor treated the infection with antibiotics. The doctor reported that the patient did not return for a follow-up.
Patient Sequence No: 1, Text Type: D, B5
[8345806]
A copy of the current medpor implant instructions for use is enclosed with caution section highlighted. This document accompanies each medpor implant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00002 |
| MDR Report Key | 1588920 |
| Report Source | 08 |
| Date Received | 2010-01-25 |
| Date of Report | 2010-01-22 |
| Date Mfgr Received | 2010-01-08 |
| Date Added to Maude | 2010-02-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KENT IVERSEN |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal | 30265 |
| Manufacturer Phone | 6784791610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR IMPLANT |
| Generic Name | FACIAL RECONSTRUCTION |
| Product Code | JAZ |
| Date Received | 2010-01-25 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-01-25 |