Brand Name | STRIDE INSERT |
Type of Device | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER |
Manufacturer (Section D) |
BLUE BELT TECHNOLOGIES |
2905 northwest blvd ste 40 |
plymouth, mn |
|
MDR Report Key | 9998638 |
MDR Text Key | 189909575 |
Report Number | 3010266064-2020-01165 |
Device Sequence Number | 1 |
Product Code |
HSX
|
Combination Product (y/n) | N |
PMA/PMN Number | K123380 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
07/29/2020 |
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 | UNKNOWN |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
10/31/2014 |
Initial Date FDA Received | 04/24/2020 |
Supplement Dates Manufacturer Received | 07/24/2020
|
Supplement Dates FDA Received | 07/29/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|