Brand Name | TPS HANDPIECE CORD |
Type of Device | DRIVER, WIRE, AND BONE DRILL, MANUAL |
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 |
casey
metzger
|
4100 east milham avenue |
kalamazoo, MI 49001
|
2693237700
|
|
MDR Report Key | 3775134 |
MDR Text Key | 4437632 |
Report Number | 0001811755-2014-01516 |
Device Sequence Number | 1 |
Product Code |
DZJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K943540 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/04/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/28/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 5100004000 |
Device Lot Number | 11252 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/07/2014 |
Date Manufacturer Received | 04/04/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/09/2011 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Treatment | ATTACHMENT 5100015250 (10035); UNIVERSAL HANDSWITCH 5100009000 (10225); REMB MICRO DRILL 6400015000 (1036303773) |