Brand Name | 3DKNEE |
Type of Device | FEMUR, NONPOROUS, 3D, SIZE8, LT |
Manufacturer (Section D) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
austin TX 78758 5445 |
|
MDR Report Key | 7397366 |
MDR Text Key | 104402694 |
Report Number | 1644408-2018-00295 |
Device Sequence Number | 1 |
Product Code |
MBH
|
UDI-Device Identifier | 00888912118989 |
UDI-Public | (01)00888912118989 |
Combination Product (y/n) | N |
PMA/PMN Number | K032905 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Type of Report
| Initial,Followup |
Report Date |
07/25/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/04/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/28/2018 |
Device Model Number | 391-09-708 |
Device Catalogue Number | 233-01-108 |
Device Lot Number | 894A1184 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 07/25/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 130-03-729, LOT 154N1004; 130-03-729, LOT 154N1004; 233-01-108, LOT 894A1184; 323-01-106, LOT 219B1013; 323-01-106, LOT 219B1013; 391-09-708, LOT 59603112 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 75 YR |
Patient Weight | 64 |
|
|