MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø3.5X10 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-03510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was discarded.
Event or Problem Description
It was reported that a yukon oct polyaxial screw broke intra-operatively.It was further reported that the surgeon changed his mind on screw length at the last minute and when he went to back out the screw it snapped.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
It was reported that a yukon oct polyaxial screw broke intra-operatively.It was further reported that the surgeon changed his mind on screw length at the last minute and when he went to back out the screw it snapped.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

• Brand Name: POLYAXIAL SCREW; SIZE Ø3.5X10 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: 15887745
• Report Number: 3004774118-2022-00408
• Device Sequence Number: 5284200
• Product Code: NKG
• UDI-Device Identifier: 10888857349292
• UDI-Public: 10888857349292
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/08/2023

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: 7601-03510
• Device Catalogue Number: 7601-03510
• Device Lot Number: UNKNOWN
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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