Brand Name | OVATION IX |
Type of Device | ILIAC LIMB |
Manufacturer (Section D) |
ENDOLOGIX SANTA ROSA |
3910 brickway blvd |
santa rosa CA 95403 |
|
Manufacturer (Section G) |
ENDOLOGIX SANTA ROSA |
3910 brickway blvd |
, |
santa rosa CA 95403 |
|
Manufacturer Contact |
gary
kirchgater
|
3910 brickway blvd |
, |
santa rosa, CA 95403
|
8009832284
|
|
MDR Report Key | 19137786 |
MDR Text Key | 340529548 |
Report Number | 3008011247-2024-00042 |
Device Sequence Number | 1 |
Product Code |
MIH
|
UDI-Device Identifier | 00850007370213 |
UDI-Public | (01)00850007370213(17)260329(10)FS032823-17 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P120006 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Remedial Action |
Other |
Type of Report
| Initial,Followup |
Report Date |
03/27/2024 |
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 Model Number | TV-IL1414120-J |
Device Lot Number | FS032823-17 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/27/2024
|
Initial Date FDA Received | 04/18/2024 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/31/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/31/2023 |
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 | ALTO MAIN BODY, LOT # FS013023-09; OVATION IX ILIAC LIMB, LOT # FS032823-19; OVATION PRIME FILL POLYMER, LOT # FF041723-01 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 75 YR |
Patient Sex | Female |
|
|