Brand Name | PIONEER SURGICAL TECHNOLOGY TRITIUM PLATE SYSTEM STERNAL PLATE |
Type of Device | STERNAL PLATE |
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 | 6812833 |
MDR Text Key | 83617967 |
Report Number | 1833824-2017-00023 |
Device Sequence Number | 1 |
Product Code |
JDQ
|
UDI-Device Identifier | 00846468049775 |
UDI-Public | (01)00846468049775(17)210120(10)234985 |
Combination Product (y/n) | N |
PMA/PMN Number | K150581 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Type of Report
| Initial |
Report Date |
08/23/2017 |
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 Expiration Date | 01/20/2021 |
Device Model Number | 86-500 |
Device Catalogue Number | SAME |
Device Lot Number | 234985 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/24/2017
|
Initial Date FDA Received | 08/23/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/20/2016 |
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 |