MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW ML; SIZE Ø4.5X34 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04534M-G1
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
Additional Manufacturer Narrative
Lot ndrk (1): device returned 26 september 2022.
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 with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Lot ndrk (1): manufacture date 28 january 2021, device returned 26 september 2022.
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 with no surgical delay and no adverse consequence to the patient.

• Brand Name: POLYAXIAL SCREW ML; SIZE Ø4.5X34 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: 15695739
• Report Number: 3004774118-2022-00366
• Device Sequence Number: 6822085
• Product Code: NKG
• UDI-Device Identifier: 10888857395640
• UDI-Public: 10888857395640
• 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: 7601-04534M-G1
• Device Catalogue Number: 7601-04534M-G1
• Device Lot Number: NDRK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• 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): Yes
• Date Device Manufactured: 01/28/2021
• 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