Brand Name | PRECICE STRYDE SYSTEM |
Type of Device | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
Manufacturer (Section D) |
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
101 enterprise dr, suite 100 |
aliso viejo CA 92656 |
|
Manufacturer (Section G) |
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
101 enterprise dr, suite 100 |
|
aliso viejo CA 92656 |
|
Manufacturer Contact |
tiara
rae
|
101 enterprise dr, suite 100 |
aliso viejo, CA 92656
|
6197314188
|
|
MDR Report Key | 11499272 |
MDR Text Key | 242786847 |
Report Number | 3006179046-2021-00198 |
Device Sequence Number | 1 |
Product Code |
HSB
|
UDI-Device Identifier | 00887517951687 |
UDI-Public | 887517951687 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K180503 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/16/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | PS11.5-80SJ280 |
Device Lot Number | 8121917 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/05/2021 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/17/2021 |
Initial Date FDA Received | 03/16/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/19/2018 |
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 |
|
|