Brand Name | STRIDE FEMORAL INS/REM IMPACTOR HEAD |
Type of Device | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
|
Manufacturer (Section G) |
BLUE BELT TECHNOLOGIES |
2905 northwest blvd ste 40 |
|
plymouth MN |
|
Manufacturer Contact |
holly
topping
|
7000 west william cannon drive |
austin, TX 78735
|
5123913905
|
|
MDR Report Key | 11008941 |
MDR Text Key | 221519758 |
Report Number | 3010266064-2020-02110 |
Device Sequence Number | 1 |
Product Code |
OLO
|
UDI-Device Identifier | 00885556627334 |
UDI-Public | 00885556627334 |
Combination Product (y/n) | N |
PMA/PMN Number | K191223 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/14/2020 |
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 | PFSR100931 |
Device Catalogue Number | PFSR100931 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/10/2020
|
Initial Date FDA Received | 12/15/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |