Brand Name | LEKSELL VANTAGE HEAD FRAME |
Type of Device | NEUROLOGICAL STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
ELEKTA INSTRUMENT AB |
kungstensgatan 18 |
po box 7593 |
stockholm, SE103 93 |
SW SE103 93 |
|
Manufacturer (Section G) |
ELEKTA INSTRUMENT AB |
kungstensgatan 18 |
po box 7593 |
stockholm, SE103 93 |
SW
SE103 93
|
|
Manufacturer Contact |
|
cornerstone |
london road |
crawley, west sussex RH10 -9BL
|
|
MDR Report Key | 17143049 |
MDR Text Key | 317681211 |
Report Number | 9612186-2023-00006 |
Device Sequence Number | 1 |
Product Code |
HAW
|
UDI-Device Identifier | 07340048305167 |
UDI-Public | 07340048305167 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K190887 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
10/20/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/16/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1051800 |
Device Catalogue Number | 1051800 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/18/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 09/24/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|