MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 4.5 MM LOCKING SCREW, 26 MM

Model Number 00-0907-4626

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2022

Event Type  malfunction  

Event Description

The patient is reviewed in consultation with rx and found a broken screw and the lost reduction.

• Brand Name: 4.5 MM LOCKING SCREW, 26 MM
• Type of Device: LOCKING 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: 16382800
• MDR Text Key: 309668704
• Report Number: 3006460162-2023-00004
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K111086
• 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: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 00-0907-4626
• Device Catalogue Number: 00-0907-4626
• Device Lot Number: 203398-G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 45 KG