Brand Name | UNKNOWN_INSTRUMENTS_PRODUCT |
Type of Device | CEMENT, BONE, VERTEBROPLASTY |
Manufacturer (Section D) |
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP |
1941 stryker way |
portage MI 49002 |
|
Manufacturer (Section G) |
STRYKER INSTRUMENTS-KALAMAZOO |
4100 east milham avenue |
|
kalamazoo MI 49001 |
|
Manufacturer Contact |
colette
chung
|
1941 stryker way |
portage, MI 49002
|
2693237700
|
|
MDR Report Key | 18924154 |
MDR Text Key | 337905777 |
Report Number | 3015967359-2024-00517 |
Device Sequence Number | 1 |
Product Code |
NDN
|
Combination Product (y/n) | N |
Reporter Country Code | PL |
PMA/PMN Number | K223294 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
03/18/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/18/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | UNK_INS |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 03/06/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|