FDA Adverse Event
Injury
Summary report: N
PEDILOC 3.5MM CONTOUR LOCKING COMPRESSION FEMUR PLATE
MDR report key: 10267696
·
Received July 13, 2020
Report
- Report Number
- 3006460162-2020-00079
- Event Type
- Injury
- Date Received
- July 13, 2020
- Date of Event
- June 3, 2020
- Report Date
- June 16, 2020
- Manufacturer
- ORTHOPEDIATRICS, CORP
- Product Code
- HRS
- PMA / PMN Number
- K140431
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DISTAL LOCKING SCREW SEEMED TO HAVE BACKED OUT OF THE RIGHT 3.5MM 8-HOLE DISTAL FEMUR PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 731769 | PEDILOC 3.5MM CONTOUR LOCKING COMPRESSION FEMUR PLATE | PEDILOC | HRS | ORTHOPEDIATRICS, CORP | 00-1065-3008 | 192730-C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR |