FDA Adverse Event
Malfunction
Summary report: N
PRECICE INTRAMEDULLARY LIMB LENGTHENING ROD
MDR report key: 2972333
·
Received February 15, 2013
Report
- Report Number
- 3006179046-2013-00003
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- January 16, 2013
- Report Date
- January 16, 2013
- Manufacturer
- ELLIPSE TECHNOLOGIES, INC.
- Product Code
- HSB
- PMA / PMN Number
- K101997
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPLANTED. TO DATE, THE PATIENT IS DOING FINE.
Description of Event or Problem · 1
THE DEVICE WAS INITIALLY IMPLANTED IN THE PATIENT ON (B)(6) 2012. THE DOCTOR ALLEGED THAT APPROXIMATELY 6 MONTHS AFTER THE INITIAL PROCEDURE, THE IMPLANT MAY HAVE BROKEN DUE TO PREMATURE WEIGHT BEARING BY THE PATIENT DURING THE CONSOLIDATION PHASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69697 | PRECICE INTRAMEDULLARY LIMB LENGTHENING ROD | INTRAMEDULLARY ROD | HSB | ELLIPSE TECHNOLOGIES, INC. | LAA2-065 | 120327-004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Other |