Brand Name | DYNAFORCE STEP STAPLE |
Type of Device | PLATE, FIXATION, BONE |
Manufacturer (Section D) |
CROSSROADS EXTREMITY SYSTEMS |
6055 primacy parkway ste 140 |
memphis, tn |
|
Manufacturer Contact |
|
6055 primacy parkway ste 140 |
memphis, tn
|
2218406
|
|
MDR Report Key | 10097286 |
MDR Text Key | 193428327 |
Report Number | 3011421599-2020-00010 |
Device Sequence Number | 1 |
Product Code |
JDR
|
Combination Product (y/n) | N |
PMA/PMN Number | K181866 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Type of Report
| Initial |
Report Date |
05/28/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/27/2020 |
Initial Date FDA Received | 05/28/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/27/2019 |
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|