Brand Name | QUICKSET ACE GRATER HEAD 62MM |
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 | 8071331 |
MDR Text Key | 127211376 |
Report Number | 1818910-2018-75517 |
Device Sequence Number | 1 |
Product Code |
HTO
|
UDI-Device Identifier | 10603295124092 |
UDI-Public | 10603295124092 |
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 |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
10/24/2018 |
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 Catalogue Number | 244000562 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/24/2018 |
Initial Date FDA Received | 11/14/2018 |
Supplement Dates Manufacturer Received | 01/14/2019
|
Supplement Dates FDA 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 |
Unknown
|
Patient Sequence Number | 1 |