MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-02-22 for MEDPOR IMPLANT 89021 manufactured by Porex Surgical, Inc..
[16270251]
The dr reported that he placed a left and right mandible implant and a chin implant on his pt. The dr stated that the right mandible implant shifted one month after surgery from its original position and the left mandible implant shifted eight months after surgery from its original position. The dr stated that the implants shifting led to an infection. The dr stated that he did not have the option of screwing the posterior part of the mandible implants to the bone because of underlying nerves and there was little bone available for fixation. The dr reported that he removed the left mandible implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2006-00003 |
| MDR Report Key | 678679 |
| Report Source | 05 |
| Date Received | 2006-02-22 |
| Date of Report | 2006-02-13 |
| Date Mfgr Received | 2006-01-27 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2006-02-27 |
| 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 ROAD |
| 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 | 2006-02-22 |
| Model Number | NA |
| Catalog Number | 89021 |
| Lot Number | A021D52H |
| ID Number | NA |
| Device Expiration Date | 2015-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 667946 |
| Manufacturer | POREX SURGICAL, INC. |
| Manufacturer Address | 15 DART RD. NEWNAN GA US |
| Baseline Brand Name | MEDPOR IMPLANT |
| Baseline Generic Name | FACIAL RECONSTRUCTION |
| Baseline Model No | NA |
| Baseline Catalog No | 89021 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-02-22 |