MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-03 for STRYKER CUSTOM CRANIAL IMPLANT KIT 54-00102 manufactured by Strker.
[976922]
Duplicate implant sent with pt, host bone destroyed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008886 |
| MDR Report Key | 1220944 |
| Date Received | 2008-11-03 |
| Date Added to Maude | 2008-11-13 |
| 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 |
| Generic Name | NONE |
| Product Code | MVA |
| Date Received | 2008-11-03 |
| Catalog Number | 54-00102 |
| Lot Number | 3130712636 |
| Device Expiration Date | 2007-11-29 |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1273665 |
| Manufacturer | STRKER |
| Brand Name | STRYKER CUSTOM CRANIAL IMPLANT KIT |
| Generic Name | NONE |
| Product Code | MVA |
| Date Received | 2008-11-03 |
| Catalog Number | 54-00103 |
| Lot Number | 1150813150 |
| Device Expiration Date | 2008-05-13 |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 2 |
| Device Event Key | 1273666 |
| Manufacturer | STRYKER |
| Brand Name | STRYKER CUSTOM CRANIAL IMPLANT KIT |
| Generic Name | NONE |
| Product Code | MVA |
| Date Received | 2008-11-03 |
| Catalog Number | 54-00103 |
| Lot Number | 0660812996 |
| Device Expiration Date | 2008-03-18 |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 3 |
| Device Event Key | 1273667 |
| Manufacturer | STRYKER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-03 |