Brand Name | RSP SHOULDER |
Type of Device | GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL |
Manufacturer (Section D) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
austin TX 78758 5445 |
|
MDR Report Key | 7631052 |
MDR Text Key | 112086083 |
Report Number | 1644408-2018-00610 |
Device Sequence Number | 1 |
Product Code |
PHX
|
UDI-Device Identifier | 00888912144667 |
UDI-Public | (01)00888912144667 |
Combination Product (y/n) | N |
PMA/PMN Number | K051075 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Type of Report
| Initial,Followup |
Report Date |
06/29/2018 |
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 | 04/10/2024 |
Device Model Number | 509-01-436 |
Device Catalogue Number | 508-36-101 |
Device Lot Number | 869C2419 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/15/2018
|
Initial Date FDA Received | 06/22/2018 |
Supplement Dates Manufacturer Received | 06/28/2018
|
Supplement Dates FDA Received | 06/29/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 508-36-101, LOT 869C2419; 509-01-436, LOT 390P1028; 508-36-101, LOT 869C2419 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 65 YR |
|
|