MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-03-16 for MEDPOR IMPLANT 89021 manufactured by Porex Surgical.
[17919182]
We did not receive information concerning the need to replace the implants from the doctor. The device history records for the lots were reviewed and all processes and test parameters were within the medpor implant specification.
Patient Sequence No: 1, Text Type: N, H10
[17971244]
The distributor stated that the doctor requested the dimensions of a medpor customized malar and mandible implants that a patient had received. The distributor stated that the doctor needed the dimensions at the time of the request because the doctor will need to do another surgery and replace the medpor customized implants. The distributor later stated that the doctor will not replace the implants but needed the information to complete a health insurance form.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-2011-00009 |
| MDR Report Key | 2020191 |
| Report Source | 08 |
| Date Received | 2011-03-16 |
| Date of Report | 2011-03-15 |
| Date Mfgr Received | 2011-02-18 |
| Device Manufacturer Date | 2010-07-15 |
| Date Added to Maude | 2012-06-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. KENT IVERSEN |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 302651017 |
| Manufacturer Country | US |
| Manufacturer Postal | 302651017 |
| Manufacturer Phone | 7702544440 |
| Manufacturer G1 | POREX SURGICAL |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30265 1017 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR IMPLANT |
| Generic Name | MEDPOR CUSTOMIZED SURGICAL IMPLANT |
| Product Code | JOF |
| Date Received | 2011-03-16 |
| Model Number | NA |
| Catalog Number | 89021 |
| Lot Number | MCI-343-10A, MCI-344-10A |
| ID Number | 510K#K083621 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA 30265101 US 30265 1017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-16 |