MAUDE Adverse Event Report: K2M, INC. IMPLANT; SIZE 24X30X15 MM, 10°; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	2013-21530L10
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A company representative reported that the chesapeake expandable drill guide disengaged from the implant during surgery while the surgeon was preparing a pilot hole for the second screw.The drill guide was not reattached and the second screw was inserted freehand into the partially prepared hole.The third screw was not implanted.The chesapeake anterior lumbar implant was placed with only two of the three screws so that the device was only instrumented to a single adjacent vertebral body.This report captures the chesapeake anterior lumbar implant.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, and no adverse trends were observed.A company representative reported that the chesapeake expandable drill guide disengaged from the implant during surgery while the surgeon was removing awl for the second screw hole.The drill guide was not reattached and the second screw was inserted freehand into the previously created pilot hole.Only 2 screws were used instead of 3.The surgery was being performed at l5-s1.The patient was closed and the surgeon intends to follow up with a posterior fixation case at a later date.Sales rep reported that the surgeon has used chesapeake in the past and the surgeon doesn't always put in three screws.Based on available information, it is likely that only 2 screws were implanted due to surgeon preference.
Event or Problem Description
A company representative reported that the chesapeake expandable drill guide disengaged from the implant during surgery while the surgeon was preparing a pilot hole for the second screw.The drill guide was not reattached and the second screw was inserted freehand into the partially prepared hole.The third screw was not implanted.The chesapeake anterior lumbar implant was placed with only two of the three screws so that the device was only instrumented to a single adjacent vertebral body.This report captures the chesapeake anterior lumbar implant.

• Brand Name: IMPLANT; SIZE 24X30X15 MM, 10°
• 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: 13654467
• Report Number: 3004774118-2022-00075
• Device Sequence Number: 14903277
• Product Code: OVD
• UDI-Device Identifier: 10888857027862
• UDI-Public: 10888857027862
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K142487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/07/2022

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: 2013-21530L10
• Device Catalogue Number: 2013-21530L10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 05/09/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 06/07/2022
• 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 Age: 54 YR
• Patient Sex: Female