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

Catalog Number	7601-05030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device remains implanted.
Event or Problem Description
A company representative reported that during routine post-operative follow-up, it was discovered that one of the yukon oct polyaxial screws fractured at t1 approximately three months after implantation.Revision surgery is not currently planned.
Event or Problem Description
A company representative reported that during routine post-operative follow-up, it was discovered that one of the yukon oct polyaxial screws fractured at t1 approximately three months after implantation.Revision surgery is not currently planned.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion h3 other text : device remains implanted.

• Brand Name: POLYAXIAL SCREW; 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: 18297560
• Report Number: 3004774118-2023-00167
• Device Sequence Number: 7358639
• Product Code: NKG
• UDI-Device Identifier: 10888857350021
• UDI-Public: 10888857350021
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/26/2024

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 Catalogue Number: 7601-05030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 04/26/2024
• 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: Male