MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW ML; SIZE Ø5.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05030M-G1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 8 months post-operatively a yukon oct polyaxial screw shank fractured at the tulip head and shank junction at t1.Revision surgery has not been performed at this time.
Additional Manufacturer Narrative
Device remains implanted.
Additional Manufacturer Narrative
H6 codes have been updated to reflect conclusion of the investigation.H3 other text: no product returned.
Event or Problem Description
A company representative reported that a patient was revised approximately 8 months after implantation to address two fractured yukon polyaxial screws at t1, one of which also migrated and one migrated yukon set screw.This report is for the first of two fractured yukon polyaxial screws.

• Brand Name: POLYAXIAL SCREW ML; SIZE Ø5.0X30 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: 15396451
• Report Number: 3004774118-2022-00335
• Device Sequence Number: 17667929
• Product Code: NKG
• UDI-Device Identifier: 10888857395831
• UDI-Public: 10888857395831
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/17/2022

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
• Operator of Device: Health Professional
• Device Model Number: 7601-05030M-G1
• Device Catalogue Number: 7601-05030M-G1
• Device Lot Number: NDRC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown