MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP DUAL ACTION ROD GRIPPERS

Model Number 01-1003-6290

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2022

Event Type  malfunction  

Event Description

Rod grippers are not adequate to rotate or reposition 5.5mm rods.They slip and do not function.Unable to derotate rod.Unable to move rod cephalad/caudad.Delay greater than 30 mins.

• Brand Name: DUAL ACTION ROD GRIPPERS
• Type of Device: ROD GRIPPERS
• 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: 15786160
• MDR Text Key: 307515813
• Report Number: 3006460162-2022-00039
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 11/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 01-1003-6290
• Device Catalogue Number: 01-1003-6290
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Female