MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 28MM

Catalog Number	00-1015-8028
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Two of the four screw heads were deformed.Situation: 2 screw's hexagonal parts were deformed or stripped which caused the removal difficult.There is no implant remained in the patient.The easyout instrument was used but it did not work at all because the screw was tightly fused to the bone and the hexagonal part was stripped.The screw head was cut off with a hospital-owned drill (carbide drill), the area around the screw was reamed, and then the screw was removed.Rr person was attended in or.Patient injury: due to the extended operation time, there was increased bleeding.

• Brand Name: 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 28MM
• Common Device Name: 4.5MM CANNULATED SCREW, CANCELLOUS THREAD, 28MM
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 20378693
• Report Number: 3006460162-2024-00052
• Device Sequence Number: 3889589
• Product Code: HWC
• UDI-Device Identifier: 00841132144756
• UDI-Public: 00841132144756
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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 Catalogue Number: 00-1015-8028
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown