MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05030
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
A physician reported that two yukon screw tulips disengaged approximately six months after implantation.Revision status is currently unknown.This report represents the first of the two screws.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.A review of complaint history records was performed and no adverse trends were observed.No further investigation can be performed due to insufficient information provided.If more information is received and/or devices are returned for evaluation this investigation will be reopened and updated.
Event or Problem Description
A physician reported that two yukon screw tulips disengaged approximately six months after implantation.Revision status is currently unknown.This report represents the first of the two screws.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X30 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10648759
• Report Number: 3004774118-2020-00227
• Device Sequence Number: 4031170
• Product Code: NKG
• UDI-Device Identifier: 10888857350021
• UDI-Public: 10888857350021
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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 Model Number: 7601-05030
• Device Catalogue Number: 7601-05030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1