MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Catalog Number UNK_SPE

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2023

Event Type  malfunction  

Event Description

It was reported that a chesapeake cage detached from the inserter during placement.The surgeon repositioned the cage and attempted to place the screws, but they would not engage with the cage, and the surgeon ultimately opted remove these devices and complete the surgery using a different cage system.There was a thirty minute surgical delay and no adverse consequence to the patient.

Manufacturer Narrative

H6 coding has been updated to reflect investigation conclusion.H3 other text : no product returned.

Event Description

It was reported that a chesapeake cage detached from the inserter during placement.The surgeon repositioned the cage and attempted to place the screws but they would not engage with the cage and the surgeon ultimately opted remove these devices and complete the surgery using a different cage system.There was a thirty minute surgical delay and no adverse consequence to the patient.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: 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: 17401853
• MDR Text Key: 320033693
• Report Number: 3004774118-2023-00097
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male