MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP SET SCREW, LARGE; PEDICLE SCREW SYSTEM

Model Number 00-1003-4001

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Set screw came loose in construct.

• Brand Name: SET SCREW, LARGE
• Type of Device: PEDICLE SCREW SYSTEM
• 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: 11233500
• MDR Text Key: 229822426
• Report Number: 3006460162-2020-00125
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150600
• 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

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00-1003-4001
• Device Catalogue Number: 00-1003-4001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 101