Brand Name | STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6 |
Type of Device | HIP CEMENTLESS STEM |
Manufacturer (Section D) |
MEDACTA INTERNATIONAL SA |
strada regina |
castel san pietro, 6874, CHE |
SZ 6874, CHE |
|
Manufacturer (Section G) |
MEDACTA INTERNATIONAL SA |
strada regina |
castel san pietro 6874, sz |
|
SZ
|
|
Manufacturer Contact |
stefano
baj
|
strada regina |
castel san pietro, switzerland 6874 -CHE
|
SZ
6874 CHE
|
|
MDR Report Key | 10389667 |
MDR Text Key | 202376560 |
Report Number | 3005180920-2020-00507 |
Device Sequence Number | 1 |
Product Code |
LZO
|
UDI-Device Identifier | 07630030885662 |
UDI-Public | 07630030885662 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K151531 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/11/2020 |
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 |
No Information
|
Device Expiration Date | 11/15/2022 |
Device Model Number | 01.39.206 |
Device Catalogue Number | 01.39.206 |
Device Lot Number | 173201 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/20/2020 |
Initial Date FDA Received | 08/11/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/28/2017 |
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;
|
|
|