MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-09-27 for MEDPOR IMPLANT 88037 manufactured by Porex Surgical.
[528466]
It was reported to the incident coordinator from the national sales manager that a patient received a medpor right and left mandible angle implant during a procedure that included a full-face lift. The right mandible was placed through the face-lift incision. To place the left mandible implant the doctor made an intra-oral incision. The left mandible implant became infected and the doctor removed the implant. A non-medpor chin implant was in place and removed the day of the surgery. The nurse reported that the patient has been on antibiotics and is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2006-00013 |
| MDR Report Key | 765539 |
| Report Source | 05 |
| Date Received | 2006-09-27 |
| Date of Report | 2006-09-25 |
| Date Mfgr Received | 2006-09-06 |
| Device Manufacturer Date | 2003-12-01 |
| Date Added to Maude | 2006-10-02 |
| 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 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR IMPLANT |
| Generic Name | FACIAL RECONSTRUCTION |
| Product Code | JAZ |
| Date Received | 2006-09-27 |
| Model Number | NA |
| Catalog Number | 88037 |
| Lot Number | 0061991203H |
| ID Number | NA |
| Device Expiration Date | 2013-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 753400 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART RD. NEWNAN GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-27 |