FDA Adverse Event
Injury
Summary report: N
IFUSE IMPLANT SYSTEM
MDR report key: 3060350
·
Received April 11, 2013
Report
- Report Number
- 3007700286-2013-00025
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 12, 2013
- Report Date
- April 11, 2013
- Manufacturer
- SI-BONE
- Product Code
- OUR
- PMA / PMN Number
- K122074
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
BASED UPON THE COMPLAINT INFO AND INVESTIGATION, AS WELL AS REVIEW OF THE SURGEON TRAINING MANUAL, IFU AND FMEA, THE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFO PROVIDED.
Description of Event or Problem · 1
THE SURGEON PERFORMED A RIGHT SIDE ARTHRODESIS ON THE PT UTILIZING THREE IFUSE IMPLANTS. THE DATE OF THE INITIAL SURGERY IS NOT KNOWN. PT HAD A RECURRENCE OF SI JOINT PAIN AFTER A PERIOD OF FEELING BETTER. PT HAD RELIEF FROM AN SI JOINT DIAGNOSTIC INJECTION. ON (B)(6) 2013, THE SURGEON PERFORMED A REVISION SURGERY AND PLACED TWO ADDITIONAL IFUSE IMPLANTS (4 X 35MM AND 4 X 40MM) TO STABILIZE THE SI JOINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154612 | IFUSE IMPLANT SYSTEM | PLATES, SCREWS, RODS | OUR | SI-BONE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |