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

Model Number	7601-10001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : device location unknown.
Event or Problem Description
It was reported via mw 5117345 that two yukon polyaxial screws at t1 fractured and two yukon set screws at that same level migrated post-operatively.The patient reportedly experienced "chronic pain" and was revised.This report captures the second of two migrated set screws.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
It was reported via mw5117345 that two yukon polyaxial screws at t1 fractured and two yukon set screws at that same level migrated post-operatively.The patient reportedly experienced "chronic pain" and was revised.This report captures the second of two migrated set screws.

• 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: 17100967
• Report Number: 3004774118-2023-00079
• Device Sequence Number: 15410521
• Product Code: NKG
• UDI-Device Identifier: 10888857328310
• UDI-Public: 10888857328310
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171444K1714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2023

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: 7601-10001
• Device Catalogue Number: 7601-10001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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