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	Mechanical Jam (2983); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a cayman united inserter would not release from the implant during surgery.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history was reviewed and no similar complaints for the reported lot number were identified.The returned device was visually inspected.The tip of the inserter was not correctly aligned and the space between the two gripping tips of the device was tight.Additionally, the distal end of the inserter shows marking from malleting.The device was functionally tested and the reported event was confirmed.Release of a sample plate was more difficult with the complaint inserter than with the sample inserter.It is determined that the device was not correctly assembled by the user following reprocessing and the incorrect alignment of the tip caused difficulty disengaging the device.The root cause of the event is misassembly of the device by the user during reprocessing.
Event or Problem Description
A company representative reported that a cayman united inserter would not release from the implant during surgery.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

• 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: 13654428
• Report Number: 3004774118-2022-00073
• Device Sequence Number: 17587429
• Product Code: OVD
• UDI-Device Identifier: 10888857383708
• UDI-Public: 10888857383708
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2019
• 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: Male
• Patient Weight: 200 KG