MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP SET SCREW, LARGE SET

Model Number 00-1003-4001

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2017

Event Type  malfunction  

Event Description

Set screw came loose product was not return as is hospital policy to scrap at location.Device was implanted on (b)(6) 2015 and removed on (b)(6) 2016 with a second revision surgery occurring on (b)(6) 2017.

• Brand Name: SET SCREW, LARGE SET
• Type of Device: SET SCREW
• 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: 16693892
• MDR Text Key: 312879064
• Report Number: 3006460162-2023-00007
• 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
• Type of Report: Initial
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 00-1003-4001
• Device Catalogue Number: 00-1003-4001
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 59 KG