Brand Name | PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM |
Type of Device | SPINE POLY-AXIAL PEDICLE SCREW |
Manufacturer (Section D) |
MEDACTA INTERNATIONAL SA |
strada regina |
castel san pietro, 6874 |
SZ 6874 |
|
Manufacturer (Section G) |
MEDACTA INTERNATIONAL SA |
strada regina |
|
castel san pietro, 6874 |
SZ
6874
|
|
Manufacturer Contact |
stefano
baj
|
strada regina |
castel san pietro, switzerland 6874
|
SZ
6874
|
|
MDR Report Key | 15174142 |
MDR Text Key | 297342019 |
Report Number | 3005180920-2022-00605 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 07630030857577 |
UDI-Public | 07630030857577 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K141988 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
08/05/2022 |
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 |
Health Professional
|
Device Model Number | 03.52.322 |
Device Catalogue Number | 03.52.322 |
Device Lot Number | 2123283 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/17/2022 |
Initial Date FDA Received | 08/05/2022 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/12/2021 |
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 Sex | Female |