FDA Adverse Event
Malfunction
Summary report: N
LOCKING PROXIMAL FEMUR PLATE SCREW
MDR report key: 3908256
·
Received May 30, 2014
Report
- Report Number
- 3006460162-2014-00007
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Report Date
- April 3, 2014
- Manufacturer
- ORTHOPEDIATRICS CORP
- Product Code
- HRS
- PMA / PMN Number
- K111086
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INTERNAL RISK ASSESSMENT (HHE) DETERMINED THAT THIS MALFUNCTION DID NOT MEET THE REQUIREMENTS OF A MANDATORY REPORTABLE ADVERSE EVENT PER 21 CFR 803.50, BUT THE FIRM WISHES TO REPORT THE MALFUNCTION.
Description of Event or Problem · 1
PT PRESENTED FOR ROUTINE FOLLOW UP AT 8 MONTHS POST OP. X-RAY REVEALED 3 BROKEN PROXIMAL SCREWS. PT OSTEOTOMY IS SOLIDLY HEALED AND PT IS ASYMPTOMATIC. ROUTINE HARDWARE REMOVAL HAS NOT BEEN SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320092 | LOCKING PROXIMAL FEMUR PLATE SCREW | BONE SCREW | HRS | ORTHOPEDIATRICS CORP | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |