MAUDE Adverse Event Report: K2M, INC. PLATE, 3 LEVEL; SIZE 57 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-43F57V
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent revision surgery to address a fractured locking mechanism on a three-level ozark plate.Two ozark screws at the level of the fractured locking mechanism migrated and "began eroding under the esophagus." this report captures the three-level ozark plate.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.H3 other text : device not returned.
Event or Problem Description
A patient underwent revision surgery to address a fractured locking mechanism on a three-level ozark plate.Two ozark screws at the level of the fractured locking mechanism migrated and "began eroding under the esophagus." this report captures the three-level ozark plate.

• Brand Name: PLATE, 3 LEVEL; SIZE 57 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: 15885673
• Report Number: 3004774118-2022-00405
• Device Sequence Number: 20101677
• Product Code: KWQ
• UDI-Device Identifier: 10888857402003
• UDI-Public: 10888857402003
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 01/31/2023

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: AA01-43F57V
• Device Catalogue Number: AA01-43F57V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female