MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-05-18 for MEDPOR IMPLANT 8329 manufactured by Porex Surgical, Inc..
[619205]
The patient had ear reconstruction surgery performed on the left ear using a medpor ear implant. During the surgery, the medpor ear implant was covered with tpf flap and skin graft. The surgeon reported that approximately six months after the surgery, a minor trauma occurred and a portion of the implant became exposed and the tissue surrounding the implant became necrotic. The surgeon stated that he explanted a portion of the medpor ear rim implant. The explanted portion of the implant was evaluated by a laboratory per the surgeon and the result was foreign body reaction with no indication of infection. The surgeon placed composite graft at the defect site to replace the portion of the medpor implant removed.
Patient Sequence No: 1, Text Type: D, B5
[7871700]
Following a review of the device history record for lot number a477e11a, it was determined that all processes and test criteria are within the medpor implant finished product specification. We have had two incidences concerning exposed ear rim implants. The mdr reporting numbers are 1057129-2006-0014 and 1057129-2007-0001.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2007-00007 |
| MDR Report Key | 852664 |
| Report Source | 05 |
| Date Received | 2007-05-18 |
| Date of Report | 2007-05-15 |
| Date of Event | 2007-03-12 |
| Date Mfgr Received | 2007-04-27 |
| Device Manufacturer Date | 2005-06-04 |
| Date Added to Maude | 2007-05-25 |
| 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 | 2007-05-18 |
| Model Number | NA |
| Catalog Number | 8329 |
| Lot Number | A477E11A |
| ID Number | NA |
| Device Expiration Date | 2015-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 840238 |
| Manufacturer | POREX SURGICAL, INC. |
| Manufacturer Address | 15 DART RD. NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-18 |