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

Model Number 7902-90033

Device Problems Fracture (1260); Material Deformation (2976)

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

Event Date 04/26/2022

Event Type  malfunction  

Event Description

It was reported that a cascadia lateral inserter broke at the tip outside the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

Manufacturer Narrative

The device was visually inspected, one of the tips of the inserter are deformed slightly off-centered causing the tips to be splayed.Normal wear and tear is observed.The inserter is able to connect to plates but requires some force to lock on and is unable to release.Device history records were reviewed for this lot, no manufacturing issues were identified.Complaint history records were reviewed for this catalog number, no adverse trends were identified.The splayed tips are consistent with improper force being applied while the inserter is in a locked/closed position.This likely caused a localized force on one of the inserter tips leading to the failure.Cayman united plate inserters should be fully retracted to the unlocked position before attempting to connect with a plate.

Event Description

It was reported that a cascadia lateral inserter broke at the tip outside the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• 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: 14470786
• MDR Text Key: 292497969
• Report Number: 3004774118-2022-00204
• 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: 08/23/2022

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
• Device Operator: Health Professional
• Device Model Number: 7902-90033
• Device Catalogue Number: 7902-90033
• Device Lot Number: JYYG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2019
• 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