MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø5.0X26 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05026
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately two months after implantation to address one fractured yukon polyaxial screw at c5 and one fractured yukon polyaxial screw at c7.It was further reported that the patient is experiencing pain.This report captures the first of the two fractured screws.
Event or Problem Description
It was reported that a patient was revised approximately two months after implantation to address one fractured yukon polyaxial screw at c5 and one fractured yukon polyaxial screw at c7.It was further reported that the patient is experiencing pain.This report captures the first of the two fractured screws.
Additional Manufacturer Narrative
H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.

• Brand Name: POLYAXIAL SCREW; SIZE Ø5.0X26 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: 15596152
• Report Number: 3004774118-2022-00354
• Device Sequence Number: 11296706
• Product Code: NKG
• UDI-Device Identifier: 10888857350007
• UDI-Public: 10888857350007
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7601-05026
• Device Catalogue Number: 7601-05026
• Device Lot Number: JKAG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown