Brand Name | JUGGERSTITCH CURVED IMPLANT |
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 | 18075760 |
MDR Text Key | 327431020 |
Report Number | 0001825034-2023-02613 |
Device Sequence Number | 1 |
Product Code |
MBI
|
UDI-Device Identifier | 00880304690073 |
UDI-Public | (01)00880304690073(17)280530(10)66101179 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K191459 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
03/07/2024 |
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 | 110024773 |
Device Lot Number | 66101179 |
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 |
10/27/2023
|
Initial Date FDA Received | 11/06/2023 |
Supplement Dates Manufacturer Received | 12/04/2023 03/05/2024
|
Supplement Dates FDA Received | 12/18/2023 03/07/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/11/2023 |
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 Sex | Prefer Not To Disclose |