Brand Name | PIONEER SURGICAL STREAMLINE MIS SYSTEM |
Type of Device | PEDICLE SCREW |
Manufacturer (Section D) |
PIONEER SURGICAL (D.B.A. RTI SURGICAL) |
375 river park circle |
marquette MI 49855 |
|
Manufacturer (Section G) |
PIONEER SURGICAL (D.B.A. RTI SURGICAL) |
375 river park circle |
|
marquette MI 49855 |
|
Manufacturer Contact |
daniel
nelson
|
375 river park circle |
marquette, MI 49855
|
9062269909
|
|
MDR Report Key | 11852178 |
MDR Text Key | 262449957 |
Report Number | 1833824-2021-00038 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130286 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
05/19/2021 |
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 | 05-PA-65-40 |
Device Catalogue Number | SAME |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/29/2021 |
Initial Date FDA Received | 05/19/2021 |
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
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |