MAUDE Adverse Event Report: K2M, INC. SELF-STARTING, VARIABLE SCREW; SIZE 4.0X16 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04016DA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that an unknown amount of ozark self-starting, variable screws fractured 4-6 months post-operatively.The patient is now experiencing neck pain.Revision surgery is not scheduled at this time.As eight screws were implanted during index surgery spanning c4, c5, c6, and c7, all eight screws will be reported conservatively.This record captures the first of eight screws.
Additional Manufacturer Narrative
B5 has been updated to reflect the correct amount of fractured screws.Functional inspection, dimensional inspection, and material analysis were unable to be performed as the device was not available for evaluation.However, screw fracture was confirmed through inspection of the associated radiographic image.The image showed that the construct was composed of a three (3) level plate, eight (8) screws, and three (3) interbodies.Both screws at the caudal-most level of the construct appear to have been fractured.A device and complaint history reviews could not be performed as a valid lot code was not identified.It is not clear what caused the screws 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.Ultimately, no root cause for the issue could be determined based on the available information.
Event or Problem Description
It was reported that two ozark self-starting, variable screws fractured 4-6 months post-operatively.The patient is now experiencing neck pain.Revision surgery is not scheduled at this time.This record captures the first of two screws.

• Brand Name: SELF-STARTING, VARIABLE SCREW; SIZE 4.0X16 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10399252
• Report Number: 3004774118-2020-00173
• Device Sequence Number: 11483186
• Product Code: KWQ
• UDI-Device Identifier: 10888857393387
• UDI-Public: 10888857393387
• 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: company representative
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8801-04016DA
• Device Catalogue Number: 8801-04016DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 08/12/2020
• 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
• Outcome Attributed to Adverse Event: Other