Brand Name | MB INSERT SZ4 9.5MM |
Type of Device | PRSVN MB INSERT SZ4 9.5MM |
Manufacturer (Section D) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
warsaw IN 46582 0998 |
|
Manufacturer (Section G) |
DEPUY IRELAND 9616671 |
loughbeg, ringaskiddy co. |
|
cork IN |
EI
|
|
Manufacturer Contact |
chad
gibson
|
700 orthopaedic drive |
warsaw, IN 46582-0998
|
5743725905
|
|
MDR Report Key | 7548779 |
MDR Text Key | 109382045 |
Report Number | 1818910-2018-60688 |
Device Sequence Number | 1 |
Product Code |
MBD
|
Combination Product (y/n) | N |
Reporter Country Code | NZ |
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,Followup |
Report Date |
04/30/2018 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 149815408 |
Device Lot Number | 1117729 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/17/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/30/2018 |
Initial Date FDA Received | 05/29/2018 |
Supplement Dates Manufacturer Received | 04/30/2018 06/22/2018 10/26/2018
|
Supplement Dates FDA Received | 05/29/2018 06/26/2018 10/28/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/02/2003 |
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;
|
Patient Age | 70 YR |