Brand Name | RSP SHOULDER |
Type of Device | GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/NEUTRAL |
Manufacturer (Section D) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
austin TX 78758 5445 |
|
MDR Report Key | 7944892 |
MDR Text Key | 123050027 |
Report Number | 1644408-2018-00934 |
Device Sequence Number | 1 |
Product Code |
PHX
|
UDI-Device Identifier | 00888912024730 |
UDI-Public | (01)00888912024730 |
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 |
10/15/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/02/2023 |
Device Model Number | 508-32-101 |
Device Catalogue Number | 508-32-101 |
Device Lot Number | 862C2383 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/24/2018
|
Initial Date FDA Received | 10/08/2018 |
Supplement Dates Manufacturer Received | 10/12/2018
|
Supplement Dates FDA Received | 10/15/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 0 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 68 YR |
|
|