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 |
|
MDR Report Key | 11033902 |
MDR Text Key | 222279881 |
Report Number | 3006179046-2020-00506 |
Device Sequence Number | 1 |
Product Code |
HSB
|
Combination Product (y/n) | N |
PMA/PMN Number | K180503 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup,Followup |
Report Date |
09/08/2021 |
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 | PS10.0-50SJ235 |
Device Catalogue Number | PS10.0-50SJ235 |
Device Lot Number | 8092801AAA |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/03/2020 |
Initial Date FDA Received | 12/17/2020 |
Supplement Dates Manufacturer Received | 07/23/2021 08/23/2021
|
Supplement Dates FDA Received | 08/10/2021 09/08/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 19 YR |
Patient Weight | 54 |
|
|