MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø4.5X26 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04526
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head of a yukon polyaxial 'broke from between head and proximal shaft' intra-operatively.Surgery was successfully completed with an unknown delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
The returned yukon oct polyaxial screw was visually inspected.The tulip head and the threaded shaft of the device were returned.The fracture occurred directly below the tulip, before the threads of the shaft begin, at the neck of the device.The shaft was observed to have severe deformation on the proximal half, which is suspected to have occurred during screw removal from the patient.This fracture site could not be inspected due to the sustained damage.The tulip head was inspected and the fracture surface appeared smooth and even.This indicates that the device fractured during an applied torsional force (i.E., insertion of the screw into hard bone).Complaint history records were reviewed for this catalog and no similar complaints were identified.Screw fracture can occur during insertion due to patient bone quality, difficult anatomy causing angulation during insertion, or improper preparation of the screw insertion site.The yukon oct surgical technique guide indicates that the desired entry point of the pedicle must be prepared using an awl, a probe, a drill, and (optionally) a tap.It is unknown if the pedicle pathway was prepared before screw insertion.In addition, higher forces may be required to insert a screw due to hard bone quality.The patient's bone quality is unknown.A conclusive root cause cannot be determined.
Event or Problem Description
It was reported that the head of a yukon polyaxial 'broke from between head and proximal shaft' intra-operatively.Surgery was successfully completed with an hour delay.No adverse consequences or medical intervention were reported.

• Brand Name: POLYAXIAL SCREW; SIZE Ø4.5X26 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13043197
• Report Number: 3004774118-2021-00405
• Device Sequence Number: 12124808
• Product Code: NKG
• UDI-Device Identifier: 10888857349797
• UDI-Public: 10888857349797
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 7601-04526
• Device Catalogue Number: 7601-04526
• Device Lot Number: 23R6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2021
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown