MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-04-09 for MEDPOR IMPLANT 9569 manufactured by Porex Surgical.
[1642277]
The surgeon reported to a porex surgical distributor that the pt received a medpor complete orbit-left implant in (b) (6) 2008. The surgeon reported that the pt received radiation therapy prior to the surgery. The surgeon stated that the primary surgery was a maxillo sinus resection of the cranial orbital area. The surgeon stated that the surgery was completed with no evidence of infection present. The surgeon reported that the pt developed an infection days after the surgery. The surgeon stated that the infection was treated with antibiotics. The surgeon reported that the implant was removed days after the surgery. The surgeon stated that the pt's condition deteriorated and the infection spread to the brain. The surgeon reported that the pt died as a result of the infection.
Patient Sequence No: 1, Text Type: D, B5
[8542165]
The device was not returned for eval however; following a review of the device history record for lot number 9569-d003d55h, it was determined that all processes and test criteria are within the medpor implant finished product specification. Contraindications listed in the medpor instructions for use state that "medpor implants should not be used in areas where there is inadequate coverage of healthy, well vascularized tissue" and :"since tissue irradiated in cancer therapy has been compromised, using medpor implants in these areas may be problematic. " this instructions for use accompanies each medpor implant sold into commerce.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00008 |
| MDR Report Key | 1657158 |
| Report Source | 05,08 |
| Date Received | 2010-04-09 |
| Date of Report | 2010-04-08 |
| Date of Event | 2008-07-01 |
| Date Mfgr Received | 2010-03-15 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2010-04-15 |
| 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 | LZK |
| Date Received | 2010-04-09 |
| Model Number | NA |
| Catalog Number | 9569 |
| Lot Number | D003D55H |
| 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. Death | 2010-04-09 |