MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø5.0X34 MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	7601-05034
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that an yukon polyaxial screw fractured at the screw/tulip interface during insertion.The shank of the screw was retained at t2 pedicle on the right making it necessary to extend the construct to t3 to provide adequate points of construct fixation.The procedure was completed with one hour surgical delay.
Additional Manufacturer Narrative
H6: coding has been updated to reflect investigation conclusion.
Event or Problem Description
A company representative reported that an yukon polyaxial screw fractured at the screw/tulip interface during insertion.The shank of the screw was retained at t2 pedicle on the right making it necessary to extend the construct to t3 to provide adequate points of construct fixation.The procedure was completed with one hour surgical delay.

• Brand Name: POLYAXIAL SCREW; SIZE Ø5.0X34 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 18080142
• Report Number: 3004774118-2023-00145
• Device Sequence Number: 12695014
• Product Code: NKG
• UDI-Device Identifier: 10888857350045
• UDI-Public: 10888857350045
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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 Catalogue Number: 7601-05034
• Device Lot Number: TRAY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female