MAUDE Adverse Event Report: K2M, INC. FIXED SCREW, SELF-STARTING; SIZE 4.0X14 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-14014DA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that an ozark view self-starting fixed screw migrated out of the plate post-operatively.The patient is not experiencing any symptoms due to the failure of the device and it is unknown if fusion was achieved.Revision surgery has not been scheduled at this time.
Additional Manufacturer Narrative
Functional inspection, dimensional inspection, visual inspection, and material analysis were unable to be performed as the device was not available for evaluation.A review of the device and complaint history records could not be performed as a valid lot code was not identified.It is not clear what caused the screw to migrate, 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.Ultimately, no root cause for the issue could be determined based on the available information.As a result, the alleged failure mode was unable to be confirmed, and no root cause for the issue was able to be determined.
Event or Problem Description
It was reported that an ozark view self-starting fixed screw migrated out of the plate post-operatively.The patient is not experiencing any symptoms due to the failure of the device and it is unknown if fusion was achieved.Revision surgery has not been scheduled at this time.

• Brand Name: FIXED SCREW, SELF-STARTING; SIZE 4.0X14 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10163993
• Report Number: 3004774118-2020-00120
• Device Sequence Number: 11533788
• Product Code: KWQ
• UDI-Device Identifier: 10888857392342
• UDI-Public: 10888857392342
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 8801-14014DA
• Device Catalogue Number: 8801-14014DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 06/17/2020
• 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