MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-03-26 for MEDPOR IMPLANT 0061550904H manufactured by Porex Surgical.
[16370975]
The assistant for the omf surgeon reported that a patient received bi-lateral malar implants intra orally in june 2005. The area where the left malar implant was placed became infected four weeks post op. The doctor treated the area with antibiotics, but when the infection did not resolve, the doctor removed the implant. The physician's assistant reported that the infection cleared since the implant was removed and the patient is doing well. The doctor is preparing to place another left malar implant.
Patient Sequence No: 1, Text Type: D, B5
[16493162]
The device history records for this lot were checked from processing to finished good and are within specification. Sterility testing was performed as required and all tests passed. Enclosed is a copy of the information insert with contraindications and cautions listed. This insert accompanies each medpor implant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2007-00006 |
| MDR Report Key | 832517 |
| Report Source | 05 |
| Date Received | 2007-03-26 |
| Date Mfgr Received | 2007-03-01 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2007-04-02 |
| 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 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 |
| 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 | 2007-03-26 |
| Model Number | NA |
| Catalog Number | 0061550904H |
| Lot Number | 7537 |
| ID Number | NA |
| Device Expiration Date | 2014-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 819839 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA * US |
| Baseline Brand Name | MEDPOR IMPLANT |
| Baseline Generic Name | FACIAL RECONSTRUCTION |
| Baseline Model No | NA |
| Baseline Catalog No | 0061550904H |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-03-26 |