Brand Name | SUMMIT CALCAR PLANER-SMALL |
Type of Device | HIP INSTRUMENTS : REAMERS |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
warsaw IN 46582 0988 |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
|
warsaw IN 46582 0988 |
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46582-0988
|
5743725905
|
|
MDR Report Key | 7479803 |
MDR Text Key | 107125432 |
Report Number | 1818910-2018-58758 |
Device Sequence Number | 1 |
Product Code |
LYS
|
UDI-Device Identifier | 10603295143178 |
UDI-Public | 10603295143178 |
Combination Product (y/n) | N |
Reporter Country Code | PL |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/09/2018 |
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 | 257004100 |
Device Lot Number | HT0409 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/30/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/09/2018 |
Initial Date FDA Received | 05/02/2018 |
Supplement Dates Manufacturer Received | 05/04/2018 06/27/2018
|
Supplement Dates FDA Received | 05/09/2018 07/04/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/15/2009 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |