MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-12-20 for MEDPOR IMPLANT 89021 manufactured by Porex Surgical.
[541486]
The doctor stated that he placed a medpor mandible implant on a pt. The doctor stated that after placing the implant, it looked as if it could become exposed. The doctor stated that the implant fit very well, but the pt had scarring and tissue degradation from a previous surgery. The doctor placed the mandible implant from an intra-oral approach and noticed post-op that there was irritation and reddening. The doctor stated that due to the scarring from the previous surgery and the overall poor condition of the surrounding tissue created by radiation, the implant may become exposed, therefore, he removed the implant. The doctor stated that he intends to perform a scar reduction procedure at a later date and will consider replacing with another medpor mandible implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2006-00015 |
| MDR Report Key | 799310 |
| Report Source | 05 |
| Date Received | 2006-12-20 |
| Date of Report | 2006-12-18 |
| Date of Event | 2006-11-28 |
| Date Mfgr Received | 2006-11-28 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2007-01-03 |
| 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 Contact | KENT IVERSEN |
| Manufacturer Street | 15 DART RD |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR IMPLANT |
| Generic Name | FACIAL RECONSTRUCTION |
| Product Code | JAZ |
| Date Received | 2006-12-20 |
| Model Number | NA |
| Catalog Number | 89021 |
| Lot Number | MCI118/06 B008F70H |
| ID Number | NA |
| Device Expiration Date | 2016-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 786828 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA * US |
| Baseline Brand Name | MEDPOR IMPLANT |
| Baseline Generic Name | FACIAL RECONSTRUCTION |
| Baseline Model No | NA |
| Baseline Catalog No | 89021 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-12-20 |