MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-10-15 for MEDPOR IMPLANT 86002 manufactured by Porex Surgical.
[1664446]
The doctor's assistant stated that they ordered a medpor chin implant for a surgery. The doctor's assistant stated that the implant broke in two during a procedure and the doctor was able to proceed by using a back-up implant.
Patient Sequence No: 1, Text Type: D, B5
[8852828]
Following a review of the device history record for lot number 86002-d285h08, it was determined that all processes and test criteria are within the medpor implant finished product specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00019 |
| MDR Report Key | 1883002 |
| Report Source | 08 |
| Date Received | 2010-10-15 |
| Date of Report | 2010-08-11 |
| Date Mfgr Received | 2010-02-25 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2011-02-03 |
| 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 | KENT IVERSEN |
| Manufacturer Street | 15 DART ROAD |
| 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 | MEDPOR IMPLANT |
| Generic Name | PREFORMED CRANFACIAL SHAPES |
| Product Code | JOF |
| Date Received | 2010-10-15 |
| Model Number | NA |
| Catalog Number | 86002 |
| Lot Number | D285H08 |
| ID Number | 510K #K922489 |
| 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 | NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-15 |