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

Catalog Number	7601-05030M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was revised to address yukon polyaxial screws fractured at t2 bilaterally.This report will capture the second of two screws.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
A patient was revised to address yukon polyaxial screws fractured at t2 bilaterally.This report will capture the second of two screws.

• Brand Name: POLYAXIAL SCREW ML; 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: 18233960
• Report Number: 3004774118-2023-00160
• Device Sequence Number: 7160957
• Product Code: NKG
• UDI-Device Identifier: 10888857351851
• UDI-Public: 10888857351851
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted 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): 03/20/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 7601-05030M
• Device Lot Number: NDRB
• 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: 10/30/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2020
• 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