MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø5.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative yukon polyaxial screw fracture.The associated procedure was completed successfully by replacing the fractured screw.There was a 30-minute surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Lot 23ga (1): device not returned by user.
Event or Problem Description
This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative yukon polyaxial screw fracture.The associated procedure was completed successfully by replacing the fractured screw.There was a 30-minute surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Lot 23ga (1): manufacture date 22 june 2021, device not returned.

• Brand Name: POLYAXIAL SCREW; SIZE Ø5.0X30 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: 15695227
• Report Number: 3004774118-2022-00369
• Device Sequence Number: 15144378
• Product Code: NKG
• UDI-Device Identifier: 10888857350021
• UDI-Public: 10888857350021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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: 7601-05030
• Device Catalogue Number: 7601-05030
• Device Lot Number: 23GA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2022
• Supplement Date Received by Manufacturer: 01/01/2023
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 57 YR
• Patient Sex: Female