Brand Name | KIVA VCF TREATMENT SYSTEM KIT FIRST FRACTURE- LEFT |
Type of Device | CEMENT, BONE, VERTEBROPLASTY |
Manufacturer (Section D) |
|
MDR Report Key | 10683361 |
MDR Text Key | 211694885 |
Report Number | MW5097224 |
Device Sequence Number | 1 |
Product Code |
NDN
|
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
10/09/2020 |
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 |
No Information
|
Device Lot Number | 20201889, 19000800 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/14/2020 |
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 69 YR |
Patient Weight | 82 |
|
|