Brand Name | OSCILLATING SAW BLADE STRYKER® SYSTEM 6 |
Type of Device | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL |
Manufacturer (Section D) |
ZIMMER SURGICAL, INC. |
200 west ohio avenue |
dover OH 44622 |
|
Manufacturer (Section G) |
ZIMMER SURGICAL, INC. |
200 west ohio avenue |
|
dover OH 44622 |
|
Manufacturer Contact |
jennifer
rapsavage
|
56 e. bell drive |
warsaw, IN 46582
|
5745260384
|
|
MDR Report Key | 14852390 |
MDR Text Key | 302420772 |
Report Number | 0001526350-2022-00628 |
Device Sequence Number | 1 |
Product Code |
GFA
|
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 |
Health Professional,User Facility |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
11/18/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 506119 |
Device Lot Number | 400759 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 06/13/2022 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/07/2022 |
Initial Date FDA Received | 06/29/2022 |
Supplement Dates Manufacturer Received | 11/16/2022
|
Supplement Dates FDA Received | 11/18/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/21/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
|
|