FDA Adverse Event
Injury
Summary report: N
ISKD INTRAMEDULLARY SKELETAL KINETIC DISTRACT
MDR report key: 1365140
·
Received April 20, 2009
Report
- Report Number
- 2183449-2009-00009
- Event Type
- Injury
- Date Received
- April 20, 2009
- Date of Event
- March 24, 2009
- Report Date
- April 17, 2009
- Manufacturer
- ORTHOFIX INC.
- Product Code
- HSB
- PMA / PMN Number
- K010322
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EXPLANTED FROM THE PT AND ANOTHER ISKB LENGTHENER WAS IMPLANTED.
Description of Event or Problem · 1
PROVIDED INFORMATION STATES THAT AFTER IMPLANTATION OF THE DEVICE, THE LENGTHENER STOPPED DISTRACTING DURING TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISKD INTRAMEDULLARY SKELETAL KINETIC DISTRACT | IMPLANTABLE LENGTHENER | HSB | ORTHOFIX INC. | F12-300-380 | 442310AP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |