Brand Name | ENCORE HUMERAL SHOULDER STEM |
Type of Device | ENCORE REVERSE SHOULDER HUMERAL STEM, STD, SZ12X175MM |
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 | 6437312 |
MDR Text Key | 70971696 |
Report Number | 1644408-2017-00177 |
Device Sequence Number | 1 |
Product Code |
PHX
|
UDI-Device Identifier | 00888912168434 |
UDI-Public | (01)00888912168434 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K141990 |
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 |
06/16/2017 |
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 | 09/22/2022 |
Device Catalogue Number | 530-12-175 |
Device Lot Number | 413T1005 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/28/2017
|
Initial Date FDA Received | 03/27/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/16/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/30/2016 |
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 | 508-32-103,LOT 864C1917; 509-00-432,LOT 385P1056 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 76 YR |
|
|