MAUDE Adverse Event Report: K2M, INC. CAYMAN UNITED 2 HOLE PLATE; SIZE 22; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	7908-42F223
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cayman united screw "went through" a cascadia cayman united two-hole plate intra-operatively.The procedure was completed successfully with a ten-minute surgical delay with no adverse consequence to the patient.This report captures the cayman united two-hole plate.
Additional Manufacturer Narrative
H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.
Event or Problem Description
It was reported that a cayman united screw "went through" a cascadia cayman united two-hole plate intra-operatively.The procedure was completed successfully with a ten-minute surgical delay with no adverse consequence to the patient.This report captures the cayman united two-hole plate.

• Brand Name: CAYMAN UNITED 2 HOLE PLATE; SIZE 22
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 15924295
• Report Number: 3004774118-2022-00409
• Device Sequence Number: 17457577
• Product Code: OVD
• UDI-Device Identifier: 10888857369153
• UDI-Public: 10888857369153
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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: 7908-42F223
• Device Catalogue Number: 7908-42F223
• Device Lot Number: TAGY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2021
• 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