MAUDE Adverse Event Report: K2M, INC. EXPANDABLE DRILL GUIDE; SIZE 15 MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	2008-90177
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
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 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 expandable drill guide.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.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.It was confirmed that no trouble was faced with the device while attaching or holding the implant.It is likely that the drill guide was not attached adequately with the implant and disengaged while removing the awl during the surgery.
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 expandable drill guide.

• Brand Name: EXPANDABLE DRILL GUIDE; SIZE 15 MM
• 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: 13654447
• Report Number: 3004774118-2022-00074
• Device Sequence Number: 5780530
• Product Code: OVD
• UDI-Device Identifier: 10888857181243
• UDI-Public: 10888857181243
• 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
• 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: 2008-90177
• Device Catalogue Number: 2008-90177
• 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): No
• 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 Age: 54 YR
• Patient Sex: Female