MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-06-10 for MEDPOR IMPLANT 89020 manufactured by Porex Surgical.
[1162740]
The doctor stated that the patient received a medpor frontal cranial implant in 2008. The doctor stated that the implant was well constructed and the results were good after the surgery. The doctor reported in 2009 that there was a breakdown of tissue in the area of the implant and he needed to replace the implant. The doctor requested a modified design of the frontal cranial implant and while awaiting the new implant, the patient developed an infection in the area and the doctor removed the implant.
Patient Sequence No: 1, Text Type: D, B5
[8459124]
Following a review of the device history record for lot 89020-mci-400-08h, it was determined that all processes and test criteria are within the medpor implant finished product specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2009-00004 |
| MDR Report Key | 1401431 |
| Report Source | 05 |
| Date Received | 2009-06-10 |
| Date of Report | 2009-06-09 |
| Date Mfgr Received | 2009-05-12 |
| Device Manufacturer Date | 2008-11-25 |
| Date Added to Maude | 2009-06-17 |
| 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 RD. |
| 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 | 2009-06-10 |
| Model Number | NA |
| Catalog Number | 89020 |
| Lot Number | MCI400-08D018M131H |
| 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 | 15 DART RD. NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-06-10 |