FDA Adverse Event
Injury
Summary report: N
INBONE FUSION ROD
MDR report key: 978179
·
Received January 9, 2008
Report
- Report Number
- 3005663955-2007-00007
- Event Type
- Injury
- Date Received
- January 9, 2008
- Date of Event
- December 10, 2007
- Report Date
- December 27, 2007
- Manufacturer
- INBONE TECHNOLOGIES
- Product Code
- HSB
- PMA / PMN Number
- K051309
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ENGINEERING PATIENT X-RAY EVALUATION DETERMINED TWO POTENTIAL SOURCES OF FAILURE: FUSION ROD PLACEMENT: THE FUSION ROD WAS INSERTED CLOSE ENOUGH TO THE BONE SCREW THAT COULD CAUSE UNDUE STRESS ON THE FUSION ROD. PATIENT POST-OP ACTIVITIES: THE POTENTIAL FOR THE PATIENT TO CAUSE THE FRACTURE DUE TO INSUFFICIENT TIME FOR HEALING. ENGINEERING COMPLETED A FEA AND CONCLUDED THE FUSION ROD MET OR EXCEEDED THE INDUSTRY STANDARD 2X STRESS FACTOR UNDER ALL CONDITIONS.
Description of Event or Problem · 1
PATIENT X-RAY APPEARS TO INDICATE FUSION ROD FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INBONE FUSION ROD | FUSION ROD | HSB | INBONE TECHNOLOGIES | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Required Intervention |