FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN ORTHOPEDIATRICS PEDILOC TIBIA SCREW
MDR report key: 7763854
·
Received August 8, 2018
Report
- Report Number
- 3006460162-2018-00060
- Event Type
- Malfunction
- Date Received
- August 8, 2018
- Report Date
- August 8, 2018
- Manufacturer
- ORTHOPEDIATRICS, INC
- Product Code
- HWC
- PMA / PMN Number
- K100240
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCOMITANT DEVICES - ITEM: 00-0903-3102, 3.5 MM NARROW MEDIAL DISTAL TIBIAL LOCKING COMPRESSION PLATE, 2-HOLE, LEFT, LOT: UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT DURING A SCHEDULED REMOVAL OF DISTAL TIBIAL LOCKING COMPRESSION PLATE, A SCREW HEAD FRACTURED OFF. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603574 | UNKNOWN ORTHOPEDIATRICS PEDILOC TIBIA SCREW | SCREW, FIXATION, BONE | HWC | ORTHOPEDIATRICS, INC | N/A | UNKNOW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |