MAUDE Adverse Event Report: K2M, INC. SET SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	7601-10001
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : screw is still implanted in patient.
Event or Problem Description
It was reported during a follow up approximately two months post-operatively that a yukon polyaxial screw at c7 experienced an unknown failure.
Event or Problem Description
A patient experienced migration of a c7 yukon set screw approximately two months after implantation.Revision surgery is not currently planned.
Additional Manufacturer Narrative
Corrected data: d4 (catalogue number), h6 (device problem code).H3 other text: screw is still implanted in patient.
Event or Problem Description
A patient experienced migration of a c7 yukon set screw approximately two months after implantation.Revision surgery is not currently planned.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.

• Brand Name: SET SCREW
• 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: 18428103
• Report Number: 3004774118-2024-00001
• Device Sequence Number: 20769285
• Product Code: NKG
• UDI-Device Identifier: 10888857349315
• UDI-Public: 10888857349315
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 06/18/2024

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: 7601-10001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/23/2024; 04/30/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 04/25/2024; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 65 YR
• Patient Sex: Male