MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; Ø5.0X32 MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	7601-05032
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : representative states screw was thrown away.
Event or Problem Description
A company representative reported that a patient was experiencing pain approximately four months after implantation and underwent revision surgery to address migration of a yukon polyaxial screw at c2 and discovered another yukon polyaxial screw fracture at t2 intra-operatively.This report captures the first of two yukon polyaxial screws.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
A company representative reported that a patient was experiencing pain approximately four months after implantation and underwent revision surgery to address migration of a yukon polyaxial screw at c2 and discovered another yukon polyaxial screw fracture at t2 intra-operatively.This report captures the first of two yukon polyaxial screws.

• Brand Name: POLYAXIAL SCREW; Ø5.0X32 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: 19143123
• Report Number: 3004774118-2024-00009
• Device Sequence Number: 18003048
• Product Code: NKG
• UDI-Device Identifier: 10888857350038
• UDI-Public: 10888857350038
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 08/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7601-05032
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown