MAUDE Adverse Event Report: K2M, INC. PLATE, 3 LEVEL; SIZE 51 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-43F51V
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that two ozark view self-starting variable screws migrated out of an fractured ozark view plate at c7 six months post-operatively.Revision surgery has not been scheduled at this time.This report will represent the plate.
Event or Problem Description
It was reported that two ozark view self-starting variable screws migrated out of an fractured ozark view plate at c7 six months post-operatively.Revision surgery has not been scheduled at this time.This report will represent the plate.
Additional Manufacturer Narrative
Visual inspection: damage to the plate was confirmed through inspection of the associated radiographic image.The image showed that the screw cover at the caudal-most level of the construct had been fractured.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.It is not clear what may have caused the screw cover to fracture, although it is possible that factors such as pseudoarthrosis contributed to the issue.If arthrodesis of the spine is not achieved then the construct may eventually fail.Even though the event was confirmed, no root cause for the issue could be determined based on the available information.

• Brand Name: PLATE, 3 LEVEL; SIZE 51 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10270997
• Report Number: 3004774118-2020-00141
• Device Sequence Number: 811088
• Product Code: KWQ
• UDI-Device Identifier: 10888857401945
• UDI-Public: 10888857401945
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• 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): 10/27/2020

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: AA01-43F51V
• Device Catalogue Number: AA01-43F51V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1