MAUDE Adverse Event Report: K2M, INC. IMPLANT; SIZE 28X36X11 MM, 10; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	2013-21136L15
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Devices remains implanted.
Event or Problem Description
A physician reported that a chesapeake screw placed in the midline position was threaded all the way through the chesapeake cage into the vertebral body.The physician removed the lateral screws and the cage before removing the midline screw.A second cage and two new lateral screws were implanted and, "the same issue occurred for a second time." the second cage and lateral screws remain implanted in the patient and, "the midline screw still within the cage, but not torqued off." there was a 45-minute surgical delay.This report captures the 2nd cage which remains implanted in the patient.
Additional Manufacturer Narrative
D4 (catalogue number corrected).
Event or Problem Description
A physician reported that a chesapeake screw placed in the midline position was threaded all the way through the chesapeake cage into the vertebral body.The physician removed the lateral screws and the cage before removing the midline screw.A second cage and two new lateral screws were implanted and, "the same issue occurred for a second time." the second cage and lateral screws remain implanted in the patient and, "the midline screw still within the cage, but not torqued off." there was a 45-minute surgical delay.This report captures the 2nd cage which remains implanted in the patient.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.  device history records review could not be performed as a valid lot code was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.A definitive root cause could not be established.
Event or Problem Description
A physician reported that a chesapeake screw placed in the midline position was threaded all the way through the chesapeake cage into the vertebral body.The physician removed the lateral screws and the cage before removing the midline screw.A second cage and two new lateral screws were implanted and, "the same issue occurred for a second time." the second cage and lateral screws remain implanted in the patient and, "the midline screw still within the cage, but not torqued off." there was a 45-minute surgical delay.This report captures the 2nd cage which remains implanted in the patient.

• Brand Name: IMPLANT; SIZE 28X36X11 MM, 10
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11489917
• Report Number: 3004774118-2021-00072
• Device Sequence Number: 3997195
• Product Code: OVD
• UDI-Device Identifier: 10888857027473
• UDI-Public: 10888857027473
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2021

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: 2013-21136L15
• Device Catalogue Number: 2013-21136L10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2021
• Supplement Date Received by Manufacturer: 04/13/2021; 06/29/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/11/2021; 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1