MAUDE Adverse Event Report: K2M, INC. SCREW, SELF-TAPPING; SIZE Ø3.85X16 MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	3601-13816
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a chesapeake screw got 'nipped' in its distal threads intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Event or Problem Description
It was reported that a chesapeake screw got 'nipped' in its distal threads intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
D4, lot #, was corrected from ¿mdcd-336800¿ to ¿armk¿ following additional information.A visual inspection was performed and deformation was observed along the distal tip of the screw threading.Device history records were reviewed for the corresponding lot and no relevant manufacturing issues were identified.A review of complaint history associated with the subject lot and catalog number was performed and no adverse trends were observed.The rep stated that the self-tapping screw was inserted at an odd angle and the screw was very difficult to initially place.It is likely that the screw was initially misaligned during insertion and collided with the implant.This excess force on the threading may have caused the deformation and led the screw to misalign, lose grip, and become unable to self-tap during final tightening.

• Brand Name: SCREW, SELF-TAPPING; SIZE Ø3.85X16 MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• 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: 14187360
• Report Number: 3004774118-2022-00156
• Device Sequence Number: 11882421
• Product Code: OVE
• UDI-Device Identifier: 10888857081154
• UDI-Public: 10888857081154
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K111439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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: 3601-13816
• Device Catalogue Number: 3601-13816
• Device Lot Number: ARMK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2011
• 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: Unknown