MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø4.5X28 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04528
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a yukon polyaxial screw fractured intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
The returned device was inspected for macroscopic indications of failure mode.The screw fractured at the neck, approximately halfway between the base of the ball and start of the shank threads.The fracture surface was mostly flat, with the fracture plane orthogonal to the screw axis.The majority of the fracture surface showed radial arced markings and a coarse, dark area near the center; all of these features are consistent with torsional overload.There was no macroscopic evidence of material defects or fatigue crack growth on the fracture surfaces.The exterior of the shank was significantly deformed, likely caused by the implement used to remove the screw from the patient after the fracture (i.E., pliers).The damage from removal caused some deformation on the circumference of the shank-side fracture face; this deformation is not related to the failure of the device.Complaint history records were reviewed for this catalog number, no adverse trends were identified.Additional information was not available from the field.A conclusive root cause could not be determined with the available information.The screw was failed in torsional overload, possibly due to the combination of stresses imparted by factors including, but not limited to: hard bone quality.Undertapping.Screw diameter.Off-label use of power tools.
Event or Problem Description
It was reported that a yukon polyaxial screw fractured intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• Brand Name: POLYAXIAL SCREW; SIZE Ø4.5X28 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: 14691404
• Report Number: 3004774118-2022-00232
• Device Sequence Number: 15126503
• Product Code: NKG
• UDI-Device Identifier: 10888857349803
• UDI-Public: 10888857349803
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: 7601-04528
• Device Catalogue Number: 7601-04528
• Device Lot Number: 249P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 09/07/2022
• 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