MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, CANNULATED; SIZE Ø8.5X90 MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number	M5111-08590
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : screws removed to be given to the patient.
Event or Problem Description
A patient was revised to address two fractured everest cannulated polyaxial screws at s1 approximately one year after implantation.This report captures the second of two everest polyaxial screws.
Event or Problem Description
A patient was revised to address two fractured everest cannulated polyaxial screws at s1 approximately one year after implantation.This report captures the second of two everest polyaxial screws.
Additional Manufacturer Narrative
H6: coding has been updated to reflect investigation conclusion.H3 other text : screws removed to be given to the patient.

• Brand Name: POLYAXIAL SCREW, CANNULATED; SIZE Ø8.5X90 MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• 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: 18347098
• Report Number: 3004774118-2023-00175
• Device Sequence Number: 12329421
• Product Code: MNI
• UDI-Device Identifier: 10888857149595
• UDI-Public: 10888857149595
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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: M5111-08590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 04/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female