Brand Name | GSS |
Type of Device | SPINAL PEDICLE FIXIATION |
Manufacturer (Section D) |
GS MEDICAL CO, LTD |
90, osongsawngmyeong 4-ro |
osong, chungcheonbugdo 28161 |
KS 28161 |
|
MDR Report Key | 6888858 |
MDR Text Key | 87192848 |
Report Number | 3008850074-2017-00001 |
Device Sequence Number | 1 |
Product Code |
MNI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Attorney
|
Type of Report
| Initial |
Report Date |
12/01/2016,09/22/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/22/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Model Number | GS161-0080, GS0161-009 |
Device Catalogue Number | GS161-0080, GS0161-009 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 12/01/2016 |
Event Location |
Hospital
|
Date Report to Manufacturer | 12/01/2016 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|