Brand Name | PERFIX SPINAL FIXATION SYSTEM |
Type of Device | SPINAL FIXATION SYSTEM |
Manufacturer (Section D) |
U&I CORPORATION |
20,sandan-ro, 76beon-gil |
uijeongbu, gyeonggi-do 11781 |
KS 11781 |
|
Manufacturer Contact |
yeo
su gil
|
20,sandan-ro,76beon-gil |
uijeongbu, gyeonggi-do 11781
|
KS
11781
|
|
MDR Report Key | 7023859 |
MDR Text Key | 91845047 |
Report Number | 9617297-2017-00005 |
Device Sequence Number | 1 |
Product Code |
MNH
|
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | K091725 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Physician
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
10/23/2017 |
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? |
No
|
Device Operator |
Physician
|
Device Catalogue Number | SNM7550 |
Device Lot Number | 15B218 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/23/2017 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/23/2017 |
Initial Date FDA Received | 11/13/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/25/2015 |
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;
|
Patient Weight | 50 |
|
|