MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-23 for MEDPOR IMPLANT 8313 manufactured by Porex Surgical.
[850750]
The doctor reported that the patient received a medpor chin implant in 2007. The doctor stated that the implant was placed intra orally and was not covered during insertion. The doctor stated that three months post op, the patient "had some trouble with the wound" and presented with a fistula on the right mandible body just beyond the lateral end of the medpor chin implant. The doctor stated that the fistula was cut out allowing it to granulate in. The doctor stated that an infection was noticed in approx eight months later. The doctor stated that the infection was treated with antibiotics. The doctor reported that the fistula returned and the implant was removed in 2008. The doctor stated that the patient is improving.
Patient Sequence No: 1, Text Type: D, B5
[8018477]
Following a review of the device history record for lot number 8313-c008b13h, it was determined that all processes and test criteria are within the medpor implant finished product specification. Enclosed is a copy of the current medpor instructions for use with contraindication highlighted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2008-00015 |
| MDR Report Key | 1050177 |
| Report Source | 05 |
| Date Received | 2008-05-23 |
| Date of Report | 2008-05-15 |
| Date of Event | 2008-04-18 |
| Date Mfgr Received | 2008-04-23 |
| Device Manufacturer Date | 2007-02-09 |
| Date Added to Maude | 2008-05-29 |
| 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 | LZK |
| Date Received | 2008-05-23 |
| Model Number | NA |
| Catalog Number | 8313 |
| Lot Number | C008B13H |
| ID Number | NA |
| Device Expiration Date | 2017-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1020403 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-05-23 |