MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 4.5MM 90° DFOS PLATE, 5° FLARE, NO OFFSET, 6 HOLE

Model Number 00-1050-6006

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

Plate was implanted to correct a valgus deformity with opening wedge osteotomy on 2/23.Patient recently notified surgeon of pain in operative site area.Originally, a small "crack" was notice in plate and the decision was made to leave implanted.However, the patient presented with the plate fully fractured and a decision was made to remove the implant.

• Brand Name: 4.5MM 90° DFOS PLATE, 5° FLARE, NO OFFSET, 6 HOLE
• Type of Device: DFOS PLATE
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN 46582
• MDR Report Key: 15539860
• MDR Text Key: 302026342
• Report Number: 3006460162-2022-00019
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 00-1050-6006
• Device Catalogue Number: 00-1050-6006
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2022
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female