FDA Adverse Event
Injury
Summary report: N
ORTHOPEDIATRICS PEDILOC TIBIAL PLATE
MDR report key: 3807425
·
Received April 15, 2014
Report
- Report Number
- 3006460162-2014-00002
- Event Type
- Injury
- Date Received
- April 15, 2014
- Report Date
- January 16, 2014
- Manufacturer
- ORTHOPEDIATRICS CORP
- Product Code
- HSB
- PMA / PMN Number
- K083726
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
HEALTH HAZARD EVALUATION CONCLUSION (RISK ASSESSMENT): RISK OF POTENTIAL OR ACTUAL SERIOUS HARM IS NOT SIGNIFICANT: PROVIDE RATIONALE: REVISION SURGERY CORRECTED OSTEOTOMY ANGLE CORRECTION LOSS.
Description of Event or Problem · 1
SURGEON REPORTED DISASSOCIATION OF LOCKING SCREWS WITH LOCKING BONE PLATE RESULTING IN LOSS OF OSTEOTOMY CORRECTION. SURGEON ALSO REPORTED POSSIBILITY THAT DRILLED HOLES WERE NOT PERPENDICULAR WITH PLATE AND CONCERN WITH USE OF DRILL GUIDES. SURGEON MISUSE IS MOST PROBABLE CAUSE OF MISALIGNED DRILL GUIDES AND NON PERPENDICULAR DRILL HOLES LEADING TO SCREWS NOT LOCKED INTO PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230807 | ORTHOPEDIATRICS PEDILOC TIBIAL PLATE | BONE PLATE | HSB | ORTHOPEDIATRICS CORP | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |