MAUDE Adverse Event Report: K2M, INC. SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X18 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	8801-04018DA
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent revision surgery to address disengagement of the locking mechanism of an ozark plate at c7 and bilateral ozark screw fractures at c3 and c7.The patient reported back pain and subsequent imaging identified the disengaged or fractured hardware.This report captures the fourth of four ozark screws.
Event or Problem Description
A patient underwent revision surgery to address disengagement of the locking mechanism of an ozark plate at c7 and bilateral ozark screw fractures at c3 and c7.The patient reported back pain and subsequent imaging identified the disengaged or fractured hardware.This report captures the fourth of four ozark screws.
Event or Problem Description
A patient underwent revision surgery to address disengagement of the locking mechanism of an ozark plate at c7 and bilateral ozark screw fractures at c3 and c7.The patient reported back pain and subsequent imaging identified the disengaged or fractured hardware.This report captures the fourth of four ozark screws.

• Brand Name: SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X18 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 18185522
• Report Number: 3004774118-2023-00153
• Device Sequence Number: 6646404
• Product Code: KWQ
• UDI-Device Identifier: 10888857393400
• UDI-Public: 10888857393400
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 03/22/2024

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: 8801-04018DA
• Device Lot Number: THPX
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 02/27/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/22/2023; 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 60 KG