MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 100° X 4.5 MM VARUS PLATE 6 MM OFFSET, 4 HOLE

Model Number 00-0907-1324

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

Surgery to remove the plaque.During this surgery they saw that the screw had been joined to the plate by means of a "cold weld" and it was very complete to remove the screw.Delay greater than 30 minutes.

• Brand Name: 100° X 4.5 MM VARUS PLATE 6 MM OFFSET, 4 HOLE
• Type of Device: VARUS 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: 13714886
• MDR Text Key: 289495873
• Report Number: 3006460162-2021-00057
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 00-0907-1324
• Device Catalogue Number: 00-0907-1324
• Device Lot Number: 641079-L032382
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1