MAUDE Adverse Event Report: K2M, INC. CAYMAN UNITED PLATE INSERTER; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 7902-90033

Device Problem Mechanical Problem (1384)

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

Event Date 06/13/2022

Event Type  malfunction  

Event Description

A company representative reported that outside the operating room a cascadia lateral plate inserter would not properly hold the plate.There were no adverse consequences to the patient.Surgery was completely successfully without surgical delay by using an alternatively available device.

Manufacturer Narrative

H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.H3 other text : device location unknown.

Event Description

A company representative reported that outside the or a cascadia lateral plate inserter would not properly hold the plate.There were no adverse consequences to the patient.Surgery was completely successfully without surgical delay by using an alternatively available device.

• Brand Name: CAYMAN UNITED PLATE INSERTER
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, 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: 14977960
• MDR Text Key: 295864874
• Report Number: 3004774118-2022-00263
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 10888857383708
• UDI-Public: 10888857383708
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172941
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7902-90033
• Device Catalogue Number: 7902-90033
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1