MAUDE Adverse Event Report: K2M, INC. PLATE, 2 LEVEL; SIZE 38 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-42F38V
Medical Device Problem Codes	Material Separation (1562); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that approximately six-months post-operatively the locking mechanism of an ozark plate broke at the c7 screw level and two ozark self-starting, variable screws migrated.Revision surgery was performed.This report captures the ozark plate.
Additional Manufacturer Narrative
H6: codes have been updated to reflect receipt of the securing mechanism of the plate and conclusion of the investigation.D9: only the disengaged securing mechanism of the plate was returned and inspected.The main device was not received back due to still being implanted.
Event or Problem Description
A company representative reported that approximately six-months post-operatively the locking mechanism of an ozark plate broke at the c7 screw level and two ozark self-starting, variable screws migrated.Revision surgery was performed.This report captures the ozark plate.

• Brand Name: PLATE, 2 LEVEL; SIZE 38 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: 16214536
• Report Number: 3004774118-2023-00004
• Device Sequence Number: 4341494
• Product Code: KWQ
• UDI-Device Identifier: 10888857401570
• UDI-Public: 10888857401570
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: 2022
• 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): 04/11/2023

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: AA01-42F38V
• Device Catalogue Number: AA01-42F38V
• 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): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 04/11/2023
• 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 Sex: Unknown