MAUDE Adverse Event Report: K2M, INC. PLATE, 2 LEVEL; SIZE 40 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-42F40V
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was revised approximately 6-months after implantation to address a fractured locking mechanism on two-level ozark plate and two migrated ozark screws at that same level (c7).The patient was noted to have achieved fusion and the explanted devices were not replaced.This report captures the two-level ozark plate.
Event or Problem Description
A patient was revised approximately 6-months after implantation to address a fractured locking mechanism on two-level ozark plate and two migrated ozark screws at that same level (c7).The patient was noted to have achieved fusion and the explanted devices were not replaced.This report captures the two-level ozark plate.
Additional Manufacturer Narrative
H6 coding has been updated to reflect device evaluation and investigation conclusion.

• Brand Name: PLATE, 2 LEVEL; SIZE 40 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: 17233431
• Report Number: 3004774118-2023-00084
• Device Sequence Number: 17553340
• Product Code: KWQ
• UDI-Device Identifier: 10888857401594
• UDI-Public: 10888857401594
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 10/05/2023

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: AA01-42F40V
• Device Catalogue Number: AA01-42F40V
• Device Lot Number: UNKNOWN
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 40 YR
• Patient Sex: Female