MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-12-02 for MEDPOR IMPLANT SEE SECTION H10 manufactured by Porex Surgical.
[1451749]
The doctor stated that he placed medpor mandible implants in two patients that developed an infection. The doctor stated that he placed the implants intraorally without an infection barrier. The doctor reported that he treated the infection with antibiotics. The doctor reported that the infection did not clear, and the implants were removed. The doctor stated that he used medpor mandible implants to replace the explanted implants.
Patient Sequence No: 1, Text Type: D, B5
[8335480]
The doctor reported the following lot numbers listed below: lot number: 7542-c334h11, expire date: 10/07/2017, manufacture date: 10/07/2007; lot number: 7541-d071d03, expire date: 4/29/2018, manufacture date: 4/29/2008; lot number: 7542-d608e04, expire date: 5/24/2018, manufacture date: 5/24/2008; lot number: 7541-c035k13 expire date: 11/16/2017, manufacture date: 11/16/2007. Following a review of the device history record for the lots listed above it was determined that all processes and test criteria are within the medpor implant finished product specification. A copy of the current medpor implant instructions for use is enclosed with caution section highlighted. This document accompanies each medpor implant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2009-00013 |
| MDR Report Key | 1555820 |
| Report Source | 08 |
| Date Received | 2009-12-02 |
| Date of Report | 2009-11-30 |
| Date Mfgr Received | 2009-11-23 |
| Device Manufacturer Date | 2007-10-07 |
| Date Added to Maude | 2009-12-11 |
| 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 | JOF |
| Date Received | 2009-12-02 |
| Model Number | NA |
| Catalog Number | SEE SECTION H10 |
| Lot Number | 7542-C334H11 |
| 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 | NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-12-02 |