MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-12-13 for MEDPOR IMPLANT 89021 manufactured by Porex Surgical.
[1764838]
The doctor stated that the patient received a medpor customized right malar implant in (b)(6) of 2010. The doctor reported that the implant was placed intra orally. The doctor stated that the patient developed an infection in (b)(6) of 2010. The doctor stated that the infection was treated with antibiotic. The doctor reported that due to the infection, he will explant the implant.
Patient Sequence No: 1, Text Type: D, B5
[8909926]
The device was not returned for evaluation however; following a review of the device history records for lot number 89021-mci-328-09a f009a02h, it was determined that all processes and test criteria are within the medpor implant finished product specification. Cautions listed in the medpor instructions for use state that "if the implants are to be placed using the intraoral route, precautions should be taken to reduce as far as possible, the risk of contaminating the implant. The use of impervious plastic film or a rubber dam to isolate the incision is recommended. " this instructions for use accompanies each medpor implant sold into commerce.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00040 |
| MDR Report Key | 1920784 |
| Report Source | 05,07 |
| Date Received | 2010-12-13 |
| Date of Report | 2010-12-09 |
| Date Mfgr Received | 2010-11-16 |
| Device Manufacturer Date | 2010-01-12 |
| Date Added to Maude | 2010-12-13 |
| 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 | MR. KENT IVERSEN |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 302651017 |
| Manufacturer Country | US |
| Manufacturer Postal | 302651017 |
| Manufacturer Phone | 6784791611 |
| Manufacturer G1 | POREX SURGICAL |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30265 1017 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR IMPLANT |
| Generic Name | MEDPOR CUSTOMIZED SURGICAL IMPLANT |
| Product Code | JOF |
| Date Received | 2010-12-13 |
| Model Number | NA |
| Catalog Number | 89021 |
| Lot Number | MCI-328-09A F009A02H |
| ID Number | 510K# K083621 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA 30265101 US 30265 1017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-12-13 |