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	Difficult or Delayed Positioning (1157); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that outside the operating room a cayman united plate inserter will no longer securely hold plates.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned, device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.It was reported that the lateral plate inserter will no longer securely hold the plate.Without the inserter to evaluate, a cause cannot be determined.Possible causes from the risk file include deformation of the tip, excessive force applied previously damaging the tip, wear from extended use, and/or rough handling during cleaning/sterilization.H3 other text : status and location of the device is unknown.
Event or Problem Description
It was reported that outside the or a cayman united plate inserter will no longer securely hold plates.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: 12857737
• Report Number: 3004774118-2021-00367
• Device Sequence Number: 4081057
• Product Code: OVD
• UDI-Device Identifier: 10888857383708
• UDI-Public: 10888857383708
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/02/2022

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: JDRY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2019
• 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