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

Catalog Number	7601-10001
Medical Device Problem Codes	Material Erosion (1214); Migration (4003)
Health Effect - Clinical Codes	Metal Related Pathology (4530); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised to address two yukon set screws that migrated post-operatively.This report is for the second of two yukon set screws.
Event or Problem Description
It was reported that a patient was revised to address two yukon set screws that migrated post-operatively.During the revision surgery, the two migrated set screws, two yukon contoured rods, and two additional yukon set screws were reported to have signs of metallosis around them.The devices were explanted.This report is for the second of two yukon set screws.
Additional Manufacturer Narrative
Corrected data: h6 coding.

• 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: 20317940
• Report Number: 3004774118-2024-00086
• Device Sequence Number: 8005261
• Product Code: NKG
• UDI-Device Identifier: 10888857328310
• UDI-Public: 10888857328310
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 12/26/2024

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: 7601-10001
• Device Lot Number: URDK
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/26/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown