MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-12-30 for MEDPOR IMPLANT 89021 manufactured by Porex Surgical.
[1765577]
The surgical supply coordinator stated that the patient received a medpor customized right mandible implant on (b)(6), 2010. The surgical supply coordinator reported that the doctor had to shave and trim the implant to get a proper fit.
Patient Sequence No: 1, Text Type: D, B5
[8926757]
The device history records were reviewed and all processes and test parameters were within the medpor implant finished goods specification. Device was implanted
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00041 |
| MDR Report Key | 1942558 |
| Report Source | 07 |
| Date Received | 2010-12-30 |
| Date of Report | 2010-12-30 |
| Date of Event | 2010-11-30 |
| Date Mfgr Received | 2010-12-01 |
| Device Manufacturer Date | 2010-04-26 |
| Date Added to Maude | 2011-01-25 |
| 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 | 6784791611 |
| 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 | 2010-12-30 |
| Model Number | NA |
| Catalog Number | 89021 |
| Lot Number | MCI-178-10 F012D49HSS |
| 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 | 2010-12-30 |