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

Model Number	7902-90033
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004774118-2022-00204
• Device Sequence Number: 4637716
• Product Code: OVD
• UDI-Device Identifier: 10888857383708
• UDI-Public: 10888857383708
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K172941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown