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

Model Number	8801-04016CA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A company representative reported that the locking mechanism of a two-level ozark plate disengaged at c6 and an ozark self-tapping screw at that level migrated.The patient has not been revised.This report captures the ozark screw.
Event or Problem Description
A company representative reported that the locking mechanism of a two-level ozark plate disengaged at c6 and an ozark self-tapping screw at that level migrated.The patient has not been revised.This report captures the ozark screw.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.

• Brand Name: SELF-TAPPING, VARIABLE SCREW; 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: 16300254
• Report Number: 3004774118-2023-00019
• Device Sequence Number: 15145480
• Product Code: KWQ
• UDI-Device Identifier: 10888857392878
• UDI-Public: 10888857392878
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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 Model Number: 8801-04016CA
• Device Catalogue Number: 8801-04016CA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 68 YR
• Patient Sex: Male