FDA Adverse Event
Injury
Summary report: N
PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD
MDR report key: 7140953
·
Received December 21, 2017
Report
- Report Number
- 3006179046-2017-00057
- Event Type
- Injury
- Date Received
- December 21, 2017
- Date of Event
- October 12, 2017
- Report Date
- October 24, 2017
- Manufacturer
- NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
- Product Code
- HSB
- PMA / PMN Number
- K141023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON REVIEWING A PATIENT'S X-RAY IMAGES AND A LENGTHENING SESSION, THEIR PRECICE NAIL APPEARED TO BE DAMAGED. THE PHYSICIAN REVISED THE NAIL WITH A NEW PRECICE NAIL, WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 919530 | PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. | P10.7-80B335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |