Brand Name | TURON SHOULDER |
Type of Device | TURON PEGGED GLENOID, SZ 46MM, EPLUS |
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 | 6814997 |
MDR Text Key | 83437919 |
Report Number | 1644408-2017-00707 |
Device Sequence Number | 1 |
Product Code |
KWS
|
UDI-Device Identifier | 00888912145374 |
UDI-Public | (01)00888912145374 |
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 |
10/23/2017 |
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 Expiration Date | 09/13/2021 |
Device Model Number | 521-01-246 |
Device Catalogue Number | 521-01-246 |
Device Lot Number | 800N1062 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/24/2017 |
Initial Date FDA Received | 08/23/2017 |
Supplement Dates Manufacturer Received | 09/25/2017
|
Supplement Dates FDA Received | 10/24/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/19/2016 |
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 878C1661; 520-01-012,LOT 456G1229; 520-50-118,LOT 934C1128 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 57 YR |
|
|