MAUDE Adverse Event Report: K2M, INC. PLATE, 4 LEVEL; SIZE 65 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number AA01-44F65V

Device Problems Fracture (1260); Material Deformation (2976); Migration (4003)

Patient Problem Pain (1994)

Event Date 10/24/2023

Event Type  Injury  

Event Description

A patient underwent revision surgery to address disengagement of the locking mechanism of an ozark plate at c7 and bilateral ozark screw fractures at c3 and c7.The patient reported back pain and subsequent imaging identified the disengaged or fractured hardware.This report captures the ozark plate.

Event Description

A patient underwent revision surgery to address disengagement of the locking mechanism of an ozark plate at c7 and bilateral ozark screw fractures at c3 and c7.The patient reported back pain and subsequent imaging identified the disengaged or fractured hardware.This report captures the ozark plate.

Manufacturer Narrative

Additional information: d4, d9, h3.

Event Description

A patient underwent revision surgery to address disengagement of the locking mechanism of an ozark plate at c7 and bilateral ozark screw fractures at c3 and c7.The patient reported back pain and subsequent imaging identified the disengaged or fractured hardware.This report captures the ozark plate.

Manufacturer Narrative

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

• Brand Name: PLATE, 4 LEVEL; SIZE 65 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: 18185520
• MDR Text Key: 328706107
• Report Number: 3004774118-2023-00154
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10888857402362
• UDI-Public: 10888857402362
• 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,Followup
• Report Date: 03/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: AA01-44F65V
• Device Lot Number: 232Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 11/27/2023; 02/27/2024
• Supplement Dates FDA Received: 12/22/2023; 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2021
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 60 KG