MAUDE Adverse Event Report: K2M, INC. YUKON OCT SPINAL SYSTEM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	7601-04540
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While implanting two separate 4.5x30mm screws into patients back the screw heads broke off.

• Brand Name: YUKON OCT SPINAL SYSTEM
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): K2M, INC.; 600 hope pkwy se; leesburg VA 20175
• MDR Report Key: 14456522
• Report Number: 14456522
• Device Sequence Number: 19982641
• Product Code: NKG
• UDI-Device Identifier: 10888857349865
• UDI-Public: (01)10888857349865
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/13/2022
• Report Date (Section F): 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7601-04540
• Device Catalogue Number: 7601-04540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 91 KG
• Date Report Sent to FDA: 05/13/2022