Brand Name | SL-PLUS AND SLR-PLUS |
Type of Device | HIP, STEM, CLP, STANDARD, SIZE#5, IMPLANT, POLISHED NECK |
Manufacturer (Section D) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
austin, tx 78758-5445, |
|
MDR Report Key | 10426244 |
MDR Text Key | 203527800 |
Report Number | 1644408-2020-00678 |
Device Sequence Number | 1 |
Product Code |
JDI
|
UDI-Device Identifier | 00888912101493 |
UDI-Public | (01)00888912101493 |
Combination Product (y/n) | N |
PMA/PMN Number | K932481 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Type of Report
| Initial,Followup |
Report Date |
09/17/2020 |
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 | 04/18/2024 |
Device Model Number | 935-36-254 |
Device Catalogue Number | 426-10-050 |
Device Lot Number | 405N1049 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/22/2020
|
Initial Date FDA Received | 08/19/2020 |
Supplement Dates Manufacturer Received | 08/20/2020
|
Supplement Dates FDA Received | 09/18/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 400-03-363 LOT 868B1203; 935-36-254 LOT 816F1036 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 45 YR |
|
|