FDA Adverse Event
Malfunction
Summary report: N
LOCKING PROXIMAL FEMUR PLATE
MDR report key: 4999182
·
Received August 11, 2015
Report
- Report Number
- 3006460162-2015-00007
- Event Type
- Malfunction
- Date Received
- August 11, 2015
- Report Date
- February 25, 2015
- Manufacturer
- ORTHOPEDIATRICS CORP
- Product Code
- HRS
- PMA / PMN Number
- K111086
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
LAB ANALYSIS INCONCLUSIVE. SURGEON NON RESPONSIVE TO INQUIRY. PLATE BENT AT 27 DEGREE PRE-OPERATIVELY.
Description of Event or Problem · 1
BROKEN LOCKING PROXIMAL FEMUR PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 526402 | LOCKING PROXIMAL FEMUR PLATE | BONE PLATE | HRS | ORTHOPEDIATRICS CORP | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |