MAUDE Adverse Event Report: K2M, INC. SCREW, SELF-TAPPING; SIZE Ø3.5X14 MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Catalog Number	3601-13514
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that, during implantation, a 3.5 x 14 mm chesapeake screw would not lock into a three-screw chesapeake titanium interbody spacer.The surgeon removed the 3.5 x 14 mm screw and attempted to place a 3.85 x 14 mm chesapeake screw instead.The second screw would not lock and, upon removing the second screw, a piece of metal was observed and removed.The surgeon determined that the interbody spacer was secure with the two appropriately locked screws and did not attempt to place the third screw a third time.This report captures the first of two chesapeake screws.
Additional Manufacturer Narrative
H3 other text : screws were discarded by the hospital and the interbody remains implanted.
Additional Manufacturer Narrative
H6: coding has been updated to reflect investigation conclusion.H3 other text: screws were discarded by the hospital and the interbody remains implanted.
Event or Problem Description
A company representative reported that, during implantation, a 3.5 x 14 mm chesapeake screw would not lock into a three-screw chesapeake titanium interbody spacer.The surgeon removed the 3.5 x 14 mm screw and attempted to place a 3.85 x 14 mm chesapeake screw instead.The second screw would not lock and, upon removing the second screw, a piece of metal was observed and removed.The surgeon determined that the interbody spacer was secure with the two appropriately locked screws and did not attempt to place the third screw a third time.This report captures the first of two chesapeake screws.

• Brand Name: SCREW, SELF-TAPPING; SIZE Ø3.5X14 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: 18337353
• Report Number: 3004774118-2023-00173
• Device Sequence Number: 8488854
• Product Code: OVE
• UDI-Device Identifier: 10888857081147
• UDI-Public: 10888857081147
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: 3601-13514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 04/04/2024
• 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 Sex: Female