MAUDE Adverse Event Report: K2M, INC. FIXED SCREW, SELF-STARTING; SIZE Ø4.0X16 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	8801-14016DA
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device remains implanted.
Event or Problem Description
It was reported that two ozark self-starting screws at c6 have fractured and the locking mechanism of an ozark plate at that same level has disengaged.The patient is asymptomatic and revision surgery is not planned.This report captures the first of the two ozark screws.
Event or Problem Description
It was reported that two ozark self-starting screws at c6 have fractured and the locking mechanism of an ozark plate at that same level has disengaged.The patient is asymptomatic and revision surgery is not planned.This report captures the first of the two ozark screws.
Additional Manufacturer Narrative
H6: codes have been updated to reflect conclusion of the investigation.

• Brand Name: FIXED SCREW, SELF-STARTING; SIZE Ø4.0X16 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: 19274361
• Report Number: 3004774118-2024-00017
• Device Sequence Number: 18057309
• Product Code: KWQ
• UDI-Device Identifier: 10888857392366
• UDI-Public: 10888857392366
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 10/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8801-14016DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Male