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

Catalog Number M5111-08590

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : screws removed to be given to the patient.

Event Description

A patient was revised to address two fractured everest cannulated polyaxial screws at s1 approximately one year after implantation.This report captures the first of two everest polyaxial screws.

Manufacturer Narrative

H6: coding has been updated to reflect investigation conclusion.H3 other text: screws removed to be given to the patient.

Event Description

A patient was revised to address two fractured everest cannulated polyaxial screws at s1 approximately one year after implantation.This report captures the first of two everest polyaxial screws.

• Brand Name: POLYAXIAL SCREW, CANNULATED; SIZE Ø8.5X90 MM
• Type of Device: 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: 18347094
• MDR Text Key: 330813622
• Report Number: 3004774118-2023-00176
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10888857149595
• UDI-Public: 10888857149595
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M5111-08590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female