Brand Name | N/A |
Type of Device | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
MEDTRONIC NAVIGATION, INC. |
826 coal creek cir |
louisville CO 80027 |
|
MDR Report Key | 12646764 |
MDR Text Key | 276918834 |
Report Number | 12646764 |
Device Sequence Number | 1 |
Product Code |
OLO
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
10/01/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/18/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 9733236 |
Device Catalogue Number | 9733236 |
Device Lot Number | 2019110399 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/22/2020 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/01/2021 |
Event Location |
Hospital
|
Date Report to Manufacturer | 10/18/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 28470 DA |
|
|