MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-29 for MEDOR IMPLANT 9536 manufactured by Porex Surgical.
[1090778]
The doctor stated that in 2006, the patient received a medpor nasal sheet implant in a revision rhinoplasty. The doctor stated that the patient had four previous rhinoplasties including a skull graft and a rib graft and had near total obstruction of the nose. The doctor stated that the patient had a large amount of scar tissue underneath the nose where the previous rib graft had been. The doctor stated that the patient tolerated the procedure well with no complication. The doctor stated that in 2007, the patient presented with a septal perforation of the nasal septum. The doctor stated that the area was closed using 6-0 nylon sutures with no problems. The doctor stated that in the following month, the patient presented with an exposed implant and infection to the area. The doctor stated the implant was removed from the infected area and reconstructed the nasal septum and columella. The doctor stated that a clean medpor implant was placed in to stabilize the nasal tip. The doctor stated that the patient tolerated the procedure well with no complications. The doctor stated that approx eight months later, the patient returned for a reconstruction of the columella and repositioning of the medpor implant.
Patient Sequence No: 1, Text Type: D, B5
[8353019]
The doctor stated that the medpor implant was cleaned, trimmed and kept in the same place as the support for the nasal tip. The doctor stated that the patient tolerated the procedure well with no complications. The doctor reported that the patient became "lost" and is seeing a doctor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2009-00006 |
| MDR Report Key | 1426028 |
| Report Source | 05 |
| Date Received | 2009-07-29 |
| Date of Report | 2009-07-23 |
| Date of Event | 2006-08-31 |
| Date Mfgr Received | 2009-07-02 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2009-08-05 |
| 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 | 3 |
| 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 | MEDOR IMPLANT |
| Generic Name | FACIAL RECONSTRUCTION |
| Product Code | JAZ |
| Date Received | 2009-07-29 |
| Model Number | NA |
| Catalog Number | 9536 |
| Lot Number | B040C06 |
| 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 | 15 DART RD. NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-07-29 |