MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE 6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-36545M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device location unknown.
Event or Problem Description
A physician reported that a patient underwent revision surgery to address a rod which had "slipped" through the screwhead of a mesa deformity uniplanar screw.The securing mechanism of the mesa screw is designed to retain the rod and keep it in place.The reported event is attributable to the screw as the rod cannot migrate when properly secured in a accurately locked screwhead.Review of the x-ray image provided shows that a second screw in the construct fractured.This record captures the fractured screw.
Event or Problem Description
A physician reported that a patient underwent revision surgery to address a rod which had "slipped" through the screwhead of a mesa deformity uniplanar screw.The securing mechanism of the mesa screw is designed to retain the rod and keep it in place.The reported event is attributable to the screw as the rod cannot migrate when properly secured in a accurately locked screwhead.Review of the x-ray image provided shows that a second screw in the construct fractured.This record captures the fractured screw.
Additional Manufacturer Narrative
Visual, dimensional, material, and functional analysis could not be performed as the device was not returned a review of the device history records could not be performed as a valid lot code was not provided and could not be obtained.It was reported the rod slipped out of the screw three months after implantation.Imaging found that the screw had fractured as well.The patient was reported to be adolescent with hard bone and unknown post-operative activity.X-rays were provided and reviewed by a consultant spine health care professional who noted that construct design with difficult deformities was the most likely a contributing factor to the event.In their analysis, the implanting surgeon used a low density screw construct ending the construct on the convex curve of the deformity.The combination of low screw density and short construct length may not have been enough to counter the force of the spine trying to revert to its original position, resulting in the eventual failure at the distal most screw where biomechanical loading is likely the greatest, leading to the rod slipping from the screw.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE 6.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11653838
• Report Number: 3004774118-2021-00109
• Device Sequence Number: 14294576
• Product Code: NKB
• UDI-Device Identifier: 10888857140301
• UDI-Public: 10888857140301
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 801-36545M
• Device Catalogue Number: 801-36545M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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: Required Intervention