MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø5.5X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	2911-05530
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product returned.
Event or Problem Description
It was reported that two (2) deformed everest polyaxial screws were left in a patient.The surgery was completed successfully with an unknown surgical delay.No adverse consequences or medical intervention were reported.This report is for the second screw.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion h3 other text : device remains implanted.
Event or Problem Description
It was reported that (b)(4) deformed everest polyaxial screws were left in a patient.The surgery was completed successfully with an unknown surgical delay.No adverse consequences or medical intervention were reported.This report is for the second screw.

• Brand Name: POLYAXIAL SCREW; SIZE Ø5.5X30 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: 15136267
• Report Number: 3004774118-2022-00309
• Device Sequence Number: 5234426
• Product Code: NKG
• UDI-Device Identifier: 10888857041851
• UDI-Public: 10888857041851
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181603
• 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): 10/21/2022

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: 2911-05530
• Device Catalogue Number: 2911-05530
• 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: 07/01/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 10/21/2022
• 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
• Patient Sex: Unknown