Brand Name | INFUSE BONE GRAFT |
Type of Device | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET |
Manufacturer (Section D) |
MEDTRONIC SOFAMOR DANEK USA, INC |
4340 swinea rd |
memphis TN 38118 |
|
Manufacturer (Section G) |
MEDTRONIC SOFAMOR DANEK USA, INC |
4340 swinea rd |
|
memphis TN 38118 |
|
Manufacturer Contact |
stacie
ziemba
|
1800 pyramid place |
memphis, TN 38132
|
9013963133
|
|
MDR Report Key | 9768046 |
MDR Text Key | 182470838 |
Report Number | 1030489-2020-00230 |
Device Sequence Number | 1 |
Product Code |
NEK
|
UDI-Device Identifier | 00613994239525 |
UDI-Public | 00613994239525 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P000058S022 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/28/2020 |
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 Catalogue Number | 7510100 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/04/2020 |
Initial Date FDA Received | 02/28/2020 |
Was Device Evaluated by Manufacturer? |
No
|
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;
|
Patient Weight | 92 |
|
|