Brand Name | DEFORMITY, UNIPLANAR SCREW; SIZE Ø6.5X45 MM |
Type of Device | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
Manufacturer (Section D) |
K2M, INC. |
600 hope parkway se |
leesburg VA 20175 |
|
Manufacturer (Section G) |
K2M, INC. |
600 hope parkway se |
|
leesburg VA 20175 |
|
Manufacturer Contact |
rita
karan
|
2 pearl court |
allendale, NJ 07401
|
2017608000
|
|
MDR Report Key | 15108536 |
MDR Text Key | 296652212 |
Report Number | 3004774118-2022-00286 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 10888857140301 |
UDI-Public | 10888857140301 |
Combination Product (y/n) | N |
Reporter Country Code | NL |
PMA/PMN Number | K141873 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician Assistant
|
Type of Report
| Initial,Followup |
Report Date |
11/04/2022 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 801-36545M |
Device Catalogue Number | 801-36545M |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/11/2022 |
Initial Date FDA Received | 07/26/2022 |
Supplement Dates Manufacturer Received | 10/07/2022
|
Supplement Dates FDA Received | 11/04/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 Age | 18 YR |
Patient Sex | Female |
|
|