Brand Name | 4.0MM X 18MM VARIABLE SCREW |
Type of Device | C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM |
Manufacturer (Section D) |
ZIMMER BIOMET SPINE, INC. |
10225 westmoor dr. |
westminster CO 80021 |
|
Manufacturer (Section G) |
ZIMMER BIOMET SPINE, INC. |
10225 westmoor dr. |
|
westminster CO 80021 |
|
Manufacturer Contact |
sabrina
abla
|
10225 westmoor dr. |
westminster, CO 80021
|
7206965158
|
|
MDR Report Key | 18061866 |
MDR Text Key | 327242819 |
Report Number | 3012447612-2023-00350 |
Device Sequence Number | 1 |
Product Code |
KWQ
|
UDI-Device Identifier | 00880304984899 |
UDI-Public | (01)00880304984899(17)260216(10)J25091 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K080646 |
Exemption Number | 5645646 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/01/2023 |
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 | 14-521618E |
Device Lot Number | J25091 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 11/02/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/16/2016 |
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;
Hospitalization;
|
Patient Sex | Male |
Patient Ethnicity | Non Hispanic |