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 | 19142301 |
MDR Text Key | 340574445 |
Report Number | 3008011247-2024-00041 |
Device Sequence Number | 1 |
Product Code |
MIH
|
UDI-Device Identifier | 00850007370121 |
UDI-Public | (01)00850007370121(17)231119(10)FS11192001 |
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 |
Report Date |
03/25/2024 |
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 Expiration Date | 11/19/2023 |
Device Model Number | TV-IL1410100-J |
Device Lot Number | FS111920-01 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/19/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/18/2020 |
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 | OVATION ALTO MAIN BODY, LT# FS070821-10; OVATION IX EXTENDER, LT# FS073021-05; OVATION IX ILIAC LIMB, LT# FS081721-31; OVATION IX ILIAC LIMB, LT# FS082721-21; OVATION PRIME FILL POLYMER, LT# FF040121-01 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 72 YR |
Patient Sex | Male |
|
|