MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.
Event or Problem Description
It was reported that a yukon oct spinal system polyaxial screw fractured intra-operatively during insertion.Surgery was successfully completed with a surgical delay using a replacement screw.
Event or Problem Description
It was reported that a yukon oct spinal system polyaxial screw fractured intra-operatively during insertion.Surgery was successfully completed with an unknown surgical delay using a replacement screw.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: screw insertion.After the pedicle screw pathway has been prepared and proper screw size has been determined, load the implant for screw insertion using a yukon screw inserter.When loading the yukon screws, grasp the implant by the screw shaft and give a slight rotation, while simultaneously applying a downward force to properly engage the screw.Once loaded, spin the knob located above the sleeve clockwise to lock the screw in place.The yukon screw inserter has a black sleeve for ease of identification.Once the screw has been loaded, insert it into the pilot hole until desired depth is reached.The screw allegedly broke off at the shank below the tulip and was removed/replaced.However, the device was reported to have been lost during spd at the hospital and was not returned for investigation.The issue could not be confirmed as the device was unavailable for inspection.Based on the available information, it appears that excessive force was applied to the screw which resulted in fracture of the device.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X30 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9875046
• Report Number: 3004774118-2020-00058
• Device Sequence Number: 19650253
• Product Code: NKG
• UDI-Device Identifier: 10888857350021
• UDI-Public: 10888857350021
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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: 7601-05030
• Device Catalogue Number: 7601-05030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1