Brand Name | TURON SHOULDER |
Type of Device | HEAD, HUMERAL, OFFSET, 50-18 |
Manufacturer (Section D) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
austin TX 78758 5445 |
|
MDR Report Key | 7383382 |
MDR Text Key | 103910221 |
Report Number | 1644408-2018-00277 |
Device Sequence Number | 1 |
Product Code |
KWS
|
UDI-Device Identifier | 00888912025058 |
UDI-Public | (01)00888912025058 |
Combination Product (y/n) | N |
PMA/PMN Number | K080402 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Type of Report
| Initial,Followup |
Report Date |
04/20/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/29/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/23/2022 |
Device Model Number | 520-50-118 |
Device Catalogue Number | 520-50-118 |
Device Lot Number | 934C1124 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/19/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 520-00-000, LOT 878C1684; 520-01-010, LOT 455G1237; 521-01-246, LOT 800N1067 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 75 YR |
|
|