MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 4.5 MM BOWED LOCKING COMPRESSION FEMUR 10 HOLE PLATE RIGHT

Model Number 00-1050-4410

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Plated fracture 10 days later patient heard a snap.

• Brand Name: 4.5 MM BOWED LOCKING COMPRESSION FEMUR 10 HOLE PLATE RIGHT
• Type of Device: BOWED LOCKING COMPRESSION FEMUR 10 HOLE PLATE RIGHT
• 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: 12267223
• MDR Text Key: 266847755
• Report Number: 3006460162-2021-00029
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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?: No
• Device Operator: No Information
• Device Model Number: 00-1050-4410
• Device Catalogue Number: 00-1050-4410
• Device Lot Number: 140177
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14 YR