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

Model Number	7601-05030M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a yukon polyaxial screw fractured intra-operatively.The event resulted in a 20 minute surgical delay.The procedure was completed successfully without any adverse consequences to the patient.
Additional Manufacturer Narrative
The implant was returned, visually and microscopically inspected.Upon review, it was observed that the screw had fractured immediately below the ball feature of the screw shank.Analysis of the fracture face indicated that the failure likely occurred in torsion.Complaint history records were reviewed for this lot, and no similar complaints were identified.Since the product was exposed to hep-c patient, a closer investigation of the implant could not be performed.Hence, a conclusive cause of the failure mode could not be determined.
Event or Problem Description
It was reported that a yukon polyaxial screw fractured intra-operatively.The event resulted in a 20 minute surgical delay.The procedure was completed successfully without and adverse consequences to the patient.

• Brand Name: POLYAXIAL SCREW ML; 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: 10696871
• Report Number: 3004774118-2020-00234
• Device Sequence Number: 3482651
• Product Code: NKG
• UDI-Device Identifier: 10888857351851
• UDI-Public: 10888857351851
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/26/2021

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: 7601-05030M
• Device Catalogue Number: 7601-05030M
• Device Lot Number: KMTX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1