MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X28 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05028
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that a yukon oct spinal system polyaxial screw head fractured intra-operatively.Surgery was successfully completed without surgical delay.There were no adverse consequences to the patient or medical intervention required.
Event or Problem Description
It was reported that a yukon oct spinal system polyaxial screw head fractured intra-operatively.As the screw was fully inserted, the shaft was left in the patient and surgery was successfully completed without surgical delay.There were no adverse consequences to the patient or medical intervention required.
Additional Manufacturer Narrative
Visual inspection: the returned head of the device was inspected, and it was observed that the screw tulip and the screw head ball was fractured from the screw shank.The fracture surface was seen to be smooth, indicating a brittle fracture.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: screw insertion.After the pedicle 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.Disengage the screw inserter by turning the knob above the sleeve counter-clockwise.The subject screw has a diameter of 05.0x28 mm which require more torque.It was reported that the physician took one additional turn with the screw driver after the screw was fully inserted.Excessive manipulation and off-axis forces may have overloaded the screw housing assemblies, resulting in the failure.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X28 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9849580
• Report Number: 3004774118-2020-00040
• Device Sequence Number: 765514
• Product Code: NKG
• UDI-Device Identifier: 10888857350014
• UDI-Public: 10888857350014
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 7601-05028
• Device Catalogue Number: 7601-05028
• Device Lot Number: JWUV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 07/25/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1