Brand Name | WASHERLOC CORTICAL SCREW 46MM |
Type of Device | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
p.o. box 587 |
warsaw IN 46581 |
|
Manufacturer (Section G) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
p.o. box 587 |
warsaw IN 46581 |
|
Manufacturer Contact |
jennifer
rapsavage
|
56 e. bell dr. |
warsaw, IN 46582
|
5745260384
|
|
MDR Report Key | 15716463 |
MDR Text Key | 307107597 |
Report Number | 0001825034-2022-02465 |
Device Sequence Number | 1 |
Product Code |
MBI
|
UDI-Device Identifier | 00880304410725 |
UDI-Public | (01)00880304410725(17)260802(10)949290 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K981967 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
12/14/2022 |
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 | 908646 |
Device Lot Number | 949290 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/11/2022 |
Initial Date FDA Received | 11/02/2022 |
Supplement Dates Manufacturer Received | 12/12/2022
|
Supplement Dates FDA Received | 12/16/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/02/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | NI |
Patient Sequence Number | 1 |