Brand Name | 3DKNEE |
Type of Device | INSERT, 3D EX SZ 6LT 9MM |
Manufacturer (Section D) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
austin TX 78758 5445 |
|
MDR Report Key | 7397362 |
MDR Text Key | 104402388 |
Report Number | 1644408-2018-00296 |
Device Sequence Number | 1 |
Product Code |
OIY
|
UDI-Device Identifier | 00888912118965 |
UDI-Public | (01)00888912118965 |
Combination Product (y/n) | N |
PMA/PMN Number | K091956 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Type of Report
| Initial,Followup |
Report Date |
04/05/2018 |
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 Model Number | 391-09-706 |
Device Catalogue Number | 391-09-706 |
Device Lot Number | 59602664 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/14/2018 |
Initial Date FDA Received | 04/04/2018 |
Supplement Dates Manufacturer Received | 04/05/2018
|
Supplement Dates FDA Received | 04/05/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 130-03-735, LOT 156N1011; 233-01-106, LOT 890A1271; 333-01-106, LOT 271B1082 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 74 YR |
Patient Weight | 76 |
|
|