MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP LRG. HUDSON TO 1/4 SQ. ADAPTER; LRG. HUDSON ADAPTER

Model Number 01-1003-5102

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Power adapter was wobbly when place on the power and did not provide a colinear screw insertion.

• Brand Name: LRG. HUDSON TO 1/4 SQ. ADAPTER
• Type of Device: LRG. HUDSON ADAPTER
• 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: 12454476
• MDR Text Key: 274788283
• Report Number: 3006460162-2021-00037
• Device Sequence Number: 1
• Product Code: NKB
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 01-1003-5102
• Device Catalogue Number: 01-1003-5102
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 45