Brand Name | TURON SHOULDER |
Type of Device | TURON PEGGED GLENOID IMPLANT, SIZE 54 |
Manufacturer (Section D) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
austin TX 78758 5445 |
|
Manufacturer (Section G) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
|
austin TX 78758 5445 |
|
Manufacturer Contact |
teffany
hutto
|
9800 metric blvd |
austin, TX 78758-5445
|
|
MDR Report Key | 7135702 |
MDR Text Key | 95414178 |
Report Number | 1644408-2017-01169 |
Device Sequence Number | 1 |
Product Code |
KWS
|
UDI-Device Identifier | 00888912145107 |
UDI-Public | (01)00888912145107 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123982 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/11/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/20/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/28/2020 |
Device Model Number | 520-01-254 |
Device Catalogue Number | 520-01-254 |
Device Lot Number | 194G1071 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 01/09/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/20/2015 |
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 |
Treatment | 520-00-000, LOT 878C1704; 520-01-012, LOT 456G1244; 520-54-122, LOT 945C1060 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 73 YR |
|
|