Brand Name | COMP RVS 3.2MM DRL |
Type of Device | INSTRUMENT, SHOULDER |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
warsaw IN 46582 |
|
MDR Report Key | 8486759 |
MDR Text Key | 141037701 |
Report Number | 0001825034-2019-01576 |
Device Sequence Number | 1 |
Product Code |
HTW
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Type of Report
| Initial,Followup |
Report Date |
04/25/2019 |
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 Model Number | N/A |
Device Catalogue Number | 405883 |
Device Lot Number | 028680 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/14/2019 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/12/2019 |
Initial Date FDA Received | 04/05/2019 |
Supplement Dates Manufacturer Received | 04/19/2019
|
Supplement Dates FDA Received | 04/25/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Treatment | (B)(4), COMPR VRS INSERTER, (B)(4); (B)(4), COMPR VRS INSERTER, 814100 |
|
|