MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-07-12 for MEDPOR CONTAIN IMPLANT 81064 manufactured by Stryker Craniomaxillofacial Georgia.
[16102138]
The doctor placed a medpor contain sheet implant and at approximately two to three months the patient presented with exposure of the medpor contain sheet implant. The doctor removed the implant.
Patient Sequence No: 1, Text Type: D, B5
[16336227]
The device history records for this lot were reviewed and all processes and test criteria are within the medpor implant specification. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2011-00021 |
| MDR Report Key | 2157401 |
| Report Source | 05,07 |
| Date Received | 2011-07-12 |
| Date of Report | 2011-07-07 |
| Date Mfgr Received | 2011-06-10 |
| Device Manufacturer Date | 2010-03-31 |
| Date Added to Maude | 2011-07-12 |
| 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. JEFF WILLIAMS |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 302651017 |
| Manufacturer Country | US |
| Manufacturer Postal | 302651017 |
| Manufacturer Phone | 7702544400 |
| Manufacturer G1 | STRYKER CRANIOMAXILLOFACIAL GEORGIA |
| 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 CONTAIN IMPLANT |
| Generic Name | IMPLANT |
| Product Code | NPK |
| Date Received | 2011-07-12 |
| Model Number | NA |
| Catalog Number | 81064 |
| Lot Number | F046C03 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CRANIOMAXILLOFACIAL GEORGIA |
| Manufacturer Address | 15 DART ROAD NEWNAN GA 30265101 US 30265 1017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-12 |