Brand Name | PIONEER SURGICAL STREAMLINE MIS PEDICLE SCREW |
Type of Device | BONE SCREW |
Manufacturer (Section D) |
PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) |
375 river park circle |
marquette MI 49855 |
|
Manufacturer (Section G) |
PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) |
375 river park circle |
|
marquette MI 49855 |
|
Manufacturer Contact |
dan
nelson
|
375 river park circle |
marquette, MI 49855
|
9062264489
|
|
MDR Report Key | 7278005 |
MDR Text Key | 100477257 |
Report Number | 1833824-2018-00004 |
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 |
Other
|
Type of Report
| Initial |
Report Date |
02/16/2018 |
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 |
Physician
|
Device Model Number | UNKNOWN |
Device Catalogue Number | UNKNOWN |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/19/2018 |
Initial Date FDA Received | 02/16/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |