MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-10-28 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.
[977226]
The doctor stated that the patient received a medpor mandibular angle/inferior border implant approximately 18 months ago without complications. The doctor stated that recently the patient developed a facial infection in the area where the implant is located. The doctor stated he could not determine a cause of the infection. The doctor stated that the patient requested removal of the implant. The doctor requested information on the removal of medpor implants. The doctor contacted a surgeon who has many years of experiences with medpor implant placement and removal. The doctor removed the implant and stated that the infection seemed to manifest at the anterior extension of the implant near the osteotomy where there was presence of a gelatinous mass but it could not be determined what caused the infection and he could not isolate it to the implant because of the location. The doctor stated that the patient is doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2008-00025 |
| MDR Report Key | 1216641 |
| Report Source | 05 |
| Date Received | 2008-10-28 |
| Date of Report | 2008-10-17 |
| Date Mfgr Received | 2008-09-25 |
| Date Added to Maude | 2008-11-06 |
| 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 | 2008-10-28 |
| 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 |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1266542 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-10-28 |