Brand Name | PRECICE SYSTEM |
Type of Device | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
Manufacturer (Section D) |
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
101 enterprise dr ste 100 |
aliso viejo CA 92656 |
|
Manufacturer Contact |
geoff
gannon
|
101 enterprise dr, ste 100 |
aliso viejo, CA 92656
|
8583448112
|
|
MDR Report Key | 15125499 |
MDR Text Key | 304434567 |
Report Number | 3006179046-2022-00235 |
Device Sequence Number | 1 |
Product Code |
HSB
|
UDI-Device Identifier | 00812258020279 |
UDI-Public | 812258020279 |
Combination Product (y/n) | N |
Reporter Country Code | TU |
PMA/PMN Number | K191336 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
08/22/2022 |
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 | P10.7-80B305 |
Device Lot Number | 1030903AAA |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/20/2022 |
Initial Date FDA Received | 07/28/2022 |
Supplement Dates Manufacturer Received | 08/19/2022
|
Supplement Dates FDA Received | 08/22/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/09/2021 |
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 Age | 41 YR |
Patient Sex | Male |
Patient Weight | 76 KG |
|
|