Brand Name | CORD 300MM |
Type of Device | THE TETHER - VERTEBRAL BODY TETHERING SYSTEM |
Manufacturer (Section D) |
ZIMMER BIOMET SPINE INC. |
10225 westmoor dr. |
westminster CO 80021 |
|
Manufacturer (Section G) |
ZIMMER BIOMET SPINE INC. |
10225 westmoor dr. |
na |
westminster CO 80021 |
|
Manufacturer Contact |
kim
martinez
|
10225 westmoor dr. |
na |
westminster, CO 80021
|
3035144809
|
|
MDR Report Key | 17083729 |
MDR Text Key | 316748219 |
Report Number | 3012447612-2023-00183 |
Device Sequence Number | 1 |
Product Code |
CET
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | H190005 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/07/2023 |
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 | 204H0300 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/15/2023 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/17/2023
|
Initial Date FDA Received | 06/07/2023 |
Was Device Evaluated by Manufacturer? |
No
|
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 Age | 13 YR |
Patient Weight | 41 KG |