MAUDE Adverse Event Report: K2M, INC. LATERAL INTERBODY; SIZE 18X50X12 MM, 8°; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6101-2185012LL8-G2
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As the screws of the plate were unable to placed, the cayman united 2 hole plate and cascadia interbody were not fixed as intended.No adverse consequences were reported at this time.This record captures the cascadia interbody.
Event or Problem Description
It was reported that the tip of the cayman mi spring loaded awl bent intra-operatively.The awl is used to prepare the bone for placement of screws.The surgeon did not elect to use or did not have on hand a back-up instrument to prepare the second screw hole.The cayman united two-hole plate and cascadia interbody were implanted but only one of two securing screws was placed.No adverse consequences to the patient have been reported and the surgeon does not plan to re-operate at this time.This record captures the cascadia interbody.
Additional Manufacturer Narrative
Visual, functional and dimensional analysis could not be performed as the device remains implanted in the patient.Device and complaint history records could not be reviewed as the device lot number was not available.It was reported that the cayman united 2 hole plate was implanted with only one screw; therefore, the cascadia lateral interbody was not able to be fixated as intended.Further investigation was not possible as the device was not available for evaluation.

• Brand Name: LATERAL INTERBODY; SIZE 18X50X12 MM, 8°
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, 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: 12558235
• Report Number: 3004774118-2021-00292
• Device Sequence Number: 11908192
• Product Code: MAX
• UDI-Device Identifier: 10888857218277
• UDI-Public: 10888857218277
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K162264
• 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): 01/14/2022

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: 6101-2185012LL8-G2
• Device Catalogue Number: 6101-2185012LL8-G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown