Brand Name | 3DKNEE |
Type of Device | FEMUR, NONPOROUS, 3D, SIZE10, RT |
Manufacturer (Section D) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
austin TX 78758 5445 |
|
MDR Report Key | 7397363 |
MDR Text Key | 104402295 |
Report Number | 1644408-2018-00297 |
Device Sequence Number | 1 |
Product Code |
MBH
|
UDI-Device Identifier | 00888912120562 |
UDI-Public | (01)00888912120562 |
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 | 01/28/2020 |
Device Model Number | 392-11-710 |
Device Catalogue Number | 233-02-110 |
Device Lot Number | 917A1124 |
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 | 130-03-735, LOT 156N1024; 130-03-735, LOT 156N1024; 233-02-110, LOT 917A1124; 333-02-110, LOT 279B1062; 333-02-110, LOT 279B1062; 392-11-710, LOT 59602614 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 60 YR |
Patient Weight | 75 |
|
|