MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø3.5X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-03530
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head of a yukon polyaxial screw broke pre-operatively.There was no procedure associated with this event.No surgical delay nor adverse consequences resulted from this issue.
Additional Manufacturer Narrative
Upon inspection and analysis of the returned device, the reported event of 'break/fracture' could not be confirmed.It was observed that the pin component was dislodged from the screw housing assembly, resulting in the disassembly of the screw.This event is not reportable as no death or serious deterioration in state of health of a patient, user, or other person has occurred or is likely to occur.
Event or Problem Description
It was reported that the head of a yukon polyaxial screw broke pre-operatively.There was no procedure associated with this event.No surgical delay nor adverse consequences resulted from this issue.

• Brand Name: POLYAXIAL SCREW; SIZE Ø3.5X30 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: 11970477
• Report Number: 3004774118-2021-00173
• Device Sequence Number: 11709703
• Product Code: NKG
• UDI-Device Identifier: 10888857349391
• UDI-Public: 10888857349391
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/21/2021

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: 7601-03530
• Device Catalogue Number: 7601-03530
• Device Lot Number: KDDH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2020
• 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