FDA Adverse Event
Injury
Summary report: N
PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD
MDR report key: 3971927
·
Received July 31, 2014
Report
- Report Number
- 3006179046-2014-00022
- Event Type
- Injury
- Date Received
- July 31, 2014
- Report Date
- July 2, 2014
- Manufacturer
- ELLIPSE TECHNOLOGIES, INCORPORATED
- Product Code
- HSB
- PMA / PMN Number
- K131677
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT HAD ALREADY COMPLETED THEIR LENGTHENING PRESCRIPTION PRIOR TO THE ALLEGED INCIDENT. THE PATIENT WAS NON-COMPLIANT; THE PATIENT REPORTED THAT HE WAS NOT USING CRUTCHES DURING TREATMENT AND WAS FULL WEIGHT BEARING. THE PRECICE NAIL WAS REMOVED AND A TRAUMA NAIL WAS IMPLANTED, WITHOUT INCIDENT. TO DATE, THE PATIENT IS DOING FINE AND NO NEGATIVE OUTCOMES HAVE BEEN NOTED. AN EVALUATION OF THE RETURNED DEVICE IS IN PROCESS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS AND THAT THE DEVICE WAS RELEASED WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
A DOCTOR ALLEGED THAT A PATIENT'S PRECICE NAIL FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 446501 | PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | ELLIPSE TECHNOLOGIES, INCORPORATED | P12.5-80B245 | A140218-08 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Hospitalization |