Brand Name | PEG FULLY THREAD |
Type of Device | PLATE, FIXATION |
Manufacturer (Section D) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
ZIMMER BIOMET, INC. |
56 e. bell drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 7379381 |
MDR Text Key | 103937087 |
Report Number | 0001825034-2018-02231 |
Device Sequence Number | 1 |
Product Code |
HRS
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | PK081546 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup |
Report Date |
06/26/2018 |
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 Model Number | N/A |
Device Catalogue Number | 131212628 |
Device Lot Number | 801240 |
Other Device ID Number | (01) 00887868012402 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/04/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/01/2018 |
Initial Date FDA Received | 03/28/2018 |
Supplement Dates Manufacturer Received | 06/25/2018
|
Supplement Dates FDA Received | 06/26/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/14/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
|
|