MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-28 for MEDPOR IMPLANT B399G13 manufactured by Porex Surgical, Inc..
[18241986]
The dr stated that he placed a medpor chin implant in his pt to add projection. The dr reported that he placed the implant intra orally and fixed the implant with two screws on each side. Two weeks after surgery, the area became infected. The dr stated that he opened the site to clean and irrigate the area to try to resolve the infection. The dr stated that he removed the implant when the infection did not resolve.
Patient Sequence No: 1, Text Type: D, B5
[18356835]
The device history records for this lot were checked from processing to finished good and is within spec. Sterility testing was performed as required and all tests passed. In the past 24 mos, we mfg 4620 pieces and distributed 3612 pieces of the chin implants. Of the 3612 pieces distributed, the complaint percentage rate for the past 24 mos is. 0014. Enclosed is a copy of the info insert with contraindications and cautions listed. This insert accompanies each medpor implant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2007-00002 |
| MDR Report Key | 823837 |
| Report Source | 05 |
| Date Received | 2007-02-28 |
| Date of Report | 2007-02-20 |
| Date of Event | 2007-01-10 |
| Date Mfgr Received | 2007-02-06 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2007-03-08 |
| 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 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 | 2007-02-28 |
| Model Number | NA |
| Catalog Number | B399G13 |
| Lot Number | 06002 |
| ID Number | NA |
| Device Expiration Date | 2016-08-01 |
| 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 | 811239 |
| Manufacturer | POREX SURGICAL, INC. |
| 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 | B399G13 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-02-28 |