Brand Name | DISCOVERY ELBOW |
Type of Device | DISC CONDYLE KIT W/ HEXALOBULA |
Manufacturer (Section D) |
ENCORE MEDICAL, L.P. |
9800 metric blvd. |
austin TX 78758 |
|
Manufacturer (Section G) |
ENCORE MEDICAL, L.P. |
9800 metric blvd. |
|
austin TX 78758 |
|
Manufacturer Contact |
teffany
hutto
|
9800 metric blvd. |
austin, TX 78758-5445
|
5128346255
|
|
MDR Report Key | 6058108 |
MDR Text Key | 58420070 |
Report Number | 1644408-2016-00859 |
Device Sequence Number | 1 |
Product Code |
JDC
|
UDI-Device Identifier | 00888912224833 |
UDI-Public | (01)00888912224833 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K051975 |
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 |
12/21/2016 |
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 | 07/31/2023 |
Device Catalogue Number | 114700 |
Device Lot Number | 191630 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/28/2016 |
Initial Date FDA Received | 10/26/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 12/21/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/31/2013 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 54 YR |
|
|