MAUDE Adverse Event Report: K2M, INC. PLATE, 2 LEVEL; SIZE 40 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number AA01-42F40V

Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 08/03/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device location unknown.

Event Description

A company representative reported that a patient was revised to address two migrated ozark screws and an ozark plate with a disengaged locking mechanism.This report captures the ozark plate.

Event Description

A company representative reported that a patient was revised to address two migrated ozark screws and an ozark plate with a disengaged locking mechanism.This report captures the ozark plate.

Manufacturer Narrative

H6 coding has been updated to reflect completion of the investigation.

• Brand Name: PLATE, 2 LEVEL; SIZE 40 MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 17666896
• MDR Text Key: 322468451
• Report Number: 3004774118-2023-00099
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AA01-42F40V
• Device Lot Number: 24MR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• 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