MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-17 for STRYKER COMMAND II 2296-234 manufactured by Stryker.
[861977]
The head of the saggittal saw came apart on the field while using on the pt's foot.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5007325 |
MDR Report Key | 1061852 |
Date Received | 2008-06-17 |
Date of Report | 2008-06-05 |
Date of Event | 2008-06-04 |
Date Added to Maude | 2008-06-25 |
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 |
Generic Name | SAGGITAL SAW |
Product Code | DZH |
Date Received | 2008-06-17 |
Model Number | COMMAND II |
Catalog Number | 2296-234 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 1030918 |
Manufacturer | STRYKER |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2008-06-17 |