FDA Adverse Event
Malfunction
Summary report: N
INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR
MDR report key: 2935724
·
Received January 3, 2013
Report
- Report Number
- 3008524126-2012-00033
- Event Type
- Malfunction
- Date Received
- January 3, 2013
- Date of Event
- August 1, 2012
- Report Date
- January 2, 2013
- Manufacturer
- ORTHOFIX INC.
- Product Code
- HSB
- PMA / PMN Number
- K010322
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
INFORMATION PROVIDED STATES THAT THE LENGTHENER WAS IMPLANTED IN (B)(6) 2012 AND STOPPED DISTRACTING. AN EXTERNAL FIXATOR WAS APPLIED OVER THE LENGTHENER AND THE PROXIMAL LOCKING SCREWS WERE REMOVED. THE LENGHTENER REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3977 | INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR | ISKD LIMB LENGTHENER | HSB | ORTHOFIX INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other |