FDA Adverse Event
Injury
Summary report: N
PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD
MDR report key: 3093047
·
Received May 3, 2013
Report
- Report Number
- 3006179046-2013-00009
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- April 5, 2013
- Report Date
- April 5, 2013
- Manufacturer
- ELLIPSE TECHNOLOGIES, INCORPORATED
- Product Code
- HSB
- PMA / PMN Number
- K101997
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
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'S PRECICE IMPLANT APPEARED TO NOT BE LENGTHENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194081 | PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD | ROD, FIXATION, INTRAMEDULLARY | HSB | ELLIPSE TECHNOLOGIES, INCORPORATED | LAA1-065 | A120712-07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Other |