MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-09 for STRYKER CUSTOM CRANIAL IMPLANT KIT - MEDIUM 54-00102 manufactured by .
[1035408]
I have checked inventory and can confirm that we do not have any affected product at this location.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009574 |
| MDR Report Key | 1284927 |
| Date Received | 2009-01-09 |
| Date Added to Maude | 2009-01-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER CUSTOM CRANIAL IMPLANT KIT - MEDIUM |
| Generic Name | NONE |
| Product Code | MVA |
| Date Received | 2009-01-09 |
| Catalog Number | 54-00102 |
| Lot Number | 1720813360 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-09 |