MAUDE Adverse Event Report: K2M, INC. PLATE, 2 LEVEL; SIZE 38 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	AA01-42F38V
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a patient with pain was revised approximately 6 months post-operatively to address one migrated ozark self-starting, variable screw at c6 and one ozark plate with a fractured locking mechanism.This report captures the plate.
Additional Manufacturer Narrative
Additional data.H6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
A company representative reported that a patient with pain was revised approximately 6 months post-operatively to address one migrated ozark self-starting, variable screw at c6 and one ozark plate with a fractured locking mechanism.This report captures the plate.

• Brand Name: PLATE, 2 LEVEL; SIZE 38 MM
• Common Device Name: 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: 19415674
• Report Number: 3004774118-2024-00027
• Device Sequence Number: 8507927
• Product Code: KWQ
• UDI-Device Identifier: 10888857401570
• UDI-Public: (01)10888857401570(11)230619(10)29DN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: AA01-42F38V
• Device Lot Number: 29DN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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: Unknown