FDA Adverse Event
Injury
Summary report: N
PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD
MDR report key: 3081643
·
Received April 29, 2013
Report
- Report Number
- 3006179046-2013-00008
- Event Type
- Injury
- Date Received
- April 29, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 1, 2013
- Manufacturer
- ELLIPSE TECHNOLOGIES, INCORPORATED
- Product Code
- HSB
- PMA / PMN Number
- K101997
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DOCTOR ATTEMPTED TO RE-OSTEOTOMIZE THE PATIENT'S FEMUR; HOWEVER, THE PROCEDURE WAS UNSUCCESSFUL. THE PATIENT'S EXISTING PRECICE NAIL WAS REMOVED AND THE PATIENT WAS IMPLANTED WITH A NEW PRECICE NAIL, WITHOUT INCIDENT. TO DATE, THE PATIENT IS DOING FINE.
Description of Event or Problem · 1
A DOCTOR ALLEGED THAT A PATIENT EXPERIENCED PREMATURE CONSOLIDATION OF THEIR FEMUR; THE BONE HARDENED BEFORE THEIR LENGTHENING TREATMENT COULD BE COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183504 | PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD | ROD, FIXATION, INTRAMEDULLARY | HSB | ELLIPSE TECHNOLOGIES, INCORPORATED | LAA2-065 | A121003-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Other |