MAUDE Adverse Event Report: ORTHOPEDIATRICS CORP. ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM; PIN, FIXATION, SMOOTH

Model Number 00-1000-030

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2018

Event Type  malfunction  

Event Description

Patient to operating room for removal of hardware.Per surgeon, original nail that was placed is bent at the tip.This is the second nail of this type that the surgeon has removed and noted this type of deformity to the implant.Implant to go to vendor for evaluation.

• Brand Name: ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ORTHOPEDIATRICS CORP.; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 9480322
• MDR Text Key: 171592266
• Report Number: 9480322
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00-1000-030
• Device Catalogue Number: 00-1000-030
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4745 DA