FDA Adverse Event
Other
Summary report: N
IFUSE IMPLANT SYSTEM
MDR report key: 3070200
·
Received April 16, 2013
Report
- Report Number
- 3007700286-2013-00026
- Event Type
- Other
- Date Received
- April 16, 2013
- Date of Event
- March 20, 2013
- Report Date
- April 17, 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
PRODUCT WAS SENT FOR HISTOLOGY ANALYSIS BY (B)(4) (THIRD PARTY ANALYSIS LABORATORY) TO ASSESS BONY IN-GROWTH. NO STRUCTURAL ANALYSIS IS PERFORMED. BASED UPON THE INFORMATION AND INVESTIGATION, AS WELL AS REVIEW OF THE SURGEON TRAINING MANUEL, IFU AND FMEA, THE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME.
Description of Event or Problem · 1
ON (B)(6) 2013, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED ONE IMPLANT (7 X 35 MM) AND REPLACED IT WITH A LONGER IMPLANT (7 X 60 MM).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 163031 | IFUSE IMPLANT SYSTEM | PLATES, SCREWS, RODS | OUR | SI-BONE | 7035-90 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |