Brand Name | NANOSS 3D ADVANCED BONE GRAFT SUBSTITUTE |
Type of Device | BONE VOID FILLER |
Manufacturer (Section D) |
PIONEER SURGICAL TECHNOLOGY |
375 river park circle |
marquette MI 49855 |
|
Manufacturer (Section G) |
PIONEER SURGICAL TECHNOLOGY |
375 river park circle |
|
marquette MI 49855 |
|
Manufacturer Contact |
casey
sumlin
|
375 river park circle |
marquette, MI 49855
|
|
MDR Report Key | 15685557 |
MDR Text Key | 302563610 |
Report Number | 1833824-2022-00136 |
Device Sequence Number | 1 |
Product Code |
MQV
|
UDI-Device Identifier | 00846468049560 |
UDI-Public | (01)00846468049560(17)230228(10)401932 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K132050 |
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 |
10/27/2022 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2023 |
Device Model Number | 90-300-251004 |
Device Catalogue Number | 90-300-251004 |
Device Lot Number | 401932 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/28/2022
|
Initial Date FDA Received | 10/27/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/19/2022 |
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 Outcome(s) |
Other;
|