MAUDE Adverse Event Report: K2M, INC. PLATE, 1 LEVEL; SIZE 16 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-41F16V
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that while a patient was undergoing an acdf revision surgery, it was observed via imaging that the locking mechanism of a one-level ozark plate had disengaged.The procedure was completed successfully with no surgical delay.
Additional Manufacturer Narrative
Corrected data: b5 h6 coding has been updated to reflect device evaluation and investigation conclusion.
Event or Problem Description
A company representative reported that during a scheduled acdf revision surgery, the surgeon observed via imaging that the locking mechanism of a one-level ozark plate had disengaged.There was no health impact to the patient, but the device was replaced at the discretion of the surgeon.

• Brand Name: PLATE, 1 LEVEL; SIZE 16 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: 16449142
• Report Number: 3004774118-2023-00026
• Device Sequence Number: 5417248
• Product Code: KWQ
• UDI-Device Identifier: 10888857401259
• UDI-Public: 10888857401259
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 06/01/2023

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: AA01-41F16V
• Device Catalogue Number: AA01-41F16V
• Device Lot Number: 222E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2020
• 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
• Patient Weight: 113 KG