Brand Name | MOTO PARTIAL KNEE TIBIAL INSERT FIX S7 LM - 9MM |
Type of Device | KNEE IMPLANT: TIBIAL INSERT FIXED |
Manufacturer (Section D) |
MEDACTA INTERNATIONAL SA |
strada regina |
castel san pietro, 6874 |
SZ 6874 |
|
Manufacturer (Section G) |
MEDACTA INTERNATIONAL SA |
strada regina |
|
castel san pietro, 6874 |
SZ
6874
|
|
Manufacturer Contact |
stefano
baj
|
strada regina |
castel san pietro, switzerland 6874
|
SZ
6874
|
|
MDR Report Key | 9738636 |
MDR Text Key | 188737672 |
Report Number | 3005180920-2020-00080 |
Device Sequence Number | 1 |
Product Code |
HSX
|
UDI-Device Identifier | 07630030896477 |
UDI-Public | 07630030896477 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K162084 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
02/21/2020 |
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 Expiration Date | 01/30/2022 |
Device Model Number | 02.18.IF7.09.LM |
Device Catalogue Number | 02.18.IF7.09.LM |
Device Lot Number | 168031 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/22/2020 |
Initial Date FDA Received | 02/21/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/16/2017 |
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;
|
Patient Age | 74 YR |