Brand Name | POLYAXIAL SCREW (DIA. 3.5 MM X 22 MM L) |
Type of Device | VIRAGE OCT SPINAL FIXATION 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 | 18367649 |
MDR Text Key | 331020778 |
Report Number | 3012447612-2023-00398 |
Device Sequence Number | 1 |
Product Code |
KWP
|
UDI-Device Identifier | 00889024327085 |
UDI-Public | (01)00889024327085(10)AAS |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K133556 |
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 |
12/19/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/20/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | 07.01702.015 |
Device Lot Number | AAS |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/16/2022 |
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 | Prefer Not To Disclose |
Patient Ethnicity | Non Hispanic |