MAUDE Adverse Event Report: K2M, INC. SCREW, SELF-TAPPING; SIZE Ø3.5X16 MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Catalog Number	3601-13516
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a chesapeake cervical ti screw was unable to be fully inserted into a chesapeake cage intra-operatively.The procedure was completed successfully using a replacement screw with a one minute surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: SCREW, SELF-TAPPING; SIZE Ø3.5X16 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 21576995
• Report Number: 3004774118-2025-00040
• Device Sequence Number: 20900981
• Product Code: OVE
• UDI-Device Identifier: 10888857081109
• UDI-Public: (01)10888857081109(11)240606(10)VTTT
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K111439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: 3601-13516
• Device Lot Number: VTTT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2024
• 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: 57 YR
• Patient Sex: Male