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 UNK manufactured by Stryker Craniomaxillofacial Georgia.
[2070290]
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
[9286543]
The doctor reported seven cases where the medpor contain sheet implant was exposed. The doctor provided lot numbers for four of the cases. The lot number information for this case was not provided by the doctor to allow for review of the device history records. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2011-00023 |
| MDR Report Key | 2157561 |
| Report Source | 05,07 |
| Date Received | 2011-07-12 |
| Date of Report | 2011-07-07 |
| Date Mfgr Received | 2011-06-10 |
| 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 | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 |