Brand Name | QUICKSET ACE GRATER HEAD 59MM |
Type of Device | HIP INSTRUMENTS : REAMERS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
warsaw IN 46582 0988 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr. |
|
warsaw IN 46582 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
1210 ward avenue |
west chester, PA 19380-XXXX
|
6103142063
|
|
MDR Report Key | 8071068 |
MDR Text Key | 127164853 |
Report Number | 1818910-2018-75507 |
Device Sequence Number | 1 |
Product Code |
HTO
|
Combination Product (Y/N) | N |
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,FOREIG |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
10/24/2018 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 11/14/2018 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device Catalogue Number | 244000559 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 01/14/2019 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unkown
|