Brand Name | UNK |
Type of Device | PLATE, FIXATION, BONE |
Manufacturer (Section D) |
ARTHREX, INC. |
1370 creekside boulevard |
naples FL 34108 1945 |
|
Manufacturer (Section G) |
ARTHREX, INC. |
1370 creekside boulevard |
|
naples FL 34108 1945 |
|
Manufacturer Contact |
|
MDR Report Key | 10666968 |
MDR Text Key | 211264171 |
Report Number | 1220246-2020-02232 |
Device Sequence Number | 1 |
Product Code |
HRS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K141478 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
10/12/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/12/2020 |
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 09/25/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|