MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-07-11 for MEDPOR IMPLANT 86001 manufactured by Porex Surgical, Inc..
[18226874]
The doctor reported that he placed a medpor chin implant intra orally and secured the implant with one screw on each side of the implant. The doctor stated that the patient had a silicone chin implant that had formed a capsule and reabsorbed some bone prior to the placement of the medpor chin implant. The doctor stated that he filled the area surrounding the medpor implant with fat. The doctor stated that an infection occurred. The doctor stated that he treated the infection with antibiotic. The doctor reported that in 2008, he removed the medpor chin implant.
Patient Sequence No: 1, Text Type: D, B5
[18343072]
Following a review of the device history record lot number 86001-a592e11, it was determined that all processes and test criteria are within the medpor implant finished product specification. A copy of the current medpor instructions for use is included with cautions highlighted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2008-00022 |
| MDR Report Key | 1079899 |
| Report Source | 05 |
| Date Received | 2008-07-11 |
| Date of Report | 2008-07-02 |
| Date of Event | 2008-03-10 |
| Date Mfgr Received | 2008-06-23 |
| Device Manufacturer Date | 2005-06-04 |
| Date Added to Maude | 2009-05-01 |
| 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 | 2008-07-11 |
| Model Number | NA |
| Catalog Number | 86001 |
| Lot Number | A592E11 |
| ID Number | NA |
| Device Expiration Date | 2015-06-01 |
| 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, INC. |
| Manufacturer Address | 15 DART RD. NEWNAN GA 30265 US 30265 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-11 |