Brand Name | OVATION IX |
Type of Device | MAIN BODY |
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 | 18475980 |
MDR Text Key | 332445674 |
Report Number | 3008011247-2024-00003 |
Device Sequence Number | 1 |
Product Code |
MIH
|
UDI-Device Identifier | M701TVAB3480J1 |
UDI-Public | +M701TVAB3480J1/$$3210625FS061818217 |
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 |
12/21/2023 |
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 | 06/25/2021 |
Device Model Number | TV-AB3480-J |
Device Lot Number | FS061818-21 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/21/2023 |
Initial Date FDA Received | 01/09/2024 |
Supplement Dates Manufacturer Received | 01/16/2024
|
Supplement Dates FDA Received | 03/06/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/20/2018 |
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 IX ILIAC LIMB, LOT # FS010518-13; OVATION IX ILIAC LIMB, LOT # FS070518-22; OVATION IX ILIAC LIMB, LOT # FS070618-18; OVATION IX ILIAC LIMB, LOT # FS071018-20; OVATION IX ILIAC LIMB, LOT # FS091818-29; OVATION PRIME FILL POLYMER, LOT # FF060418-02 |
Patient Outcome(s) |
Required Intervention;
Other;
|
Patient Age | 71 YR |
Patient Sex | Male |
|
|