Brand Name | CAST CUTTER |
Type of Device | SAW, POWERED, AND ACCESSORIES |
Manufacturer (Section D) |
STRYKER INSTRUMENTS-KALAMAZOO |
4100 east milham avenue |
kalamazoo MI 49001 |
|
Manufacturer (Section G) |
STRYKER INSTRUMENTS-KALAMAZOO |
4100 east milham avenue |
|
kalamazoo MI 49001 |
|
Manufacturer Contact |
zachary
baker
|
4100 east milham avenue |
kalamazoo, MI 49001
|
2693237700
|
|
MDR Report Key | 7004903 |
MDR Text Key | 91182091 |
Report Number | 0001811755-2017-02336 |
Device Sequence Number | 1 |
Product Code |
HAB
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
USER FACILITY |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
05/15/2018 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 11/06/2017 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
HEALTH PROFESSIONAL
|
Device Catalogue Number | 0940000000 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 05/04/2018 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient TREATMENT DATA |
Date Received: 11/06/2017 Patient Sequence Number: 1 |
|
|