Brand Name | NANOBONE SBX PUTTY |
Type of Device | BONE VOID FILLER, PRODUCT CODE: MQV |
Manufacturer (Section D) |
ARTOSS GMBH |
fischerweg 421 |
rostock, 18069 |
GM 18069 |
|
Manufacturer (Section G) |
ARTOSS GMBH |
fischerweg 421 |
|
rostock, 18069 |
GM
18069
|
|
Manufacturer Contact |
walter
gerike
|
fischerweg 421 |
rostock, 18069
|
GM
18069
|
|
MDR Report Key | 16527990 |
MDR Text Key | 311133040 |
Report Number | 3011483489-2020-00005 |
Device Sequence Number | 1 |
Product Code |
MQV
|
UDI-Device Identifier | 14260418440468 |
UDI-Public | (01)14260418440468(10)004823(17)221008 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K190110 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
09/02/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/13/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/08/2022 |
Device Model Number | 200046 |
Device Lot Number | 004823 |
Date Manufacturer Received | 09/02/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/16/2019 |
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) |
Required Intervention;
|
Patient Age | 50 YR |
Patient Sex | Male |
Patient Weight | 64 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |