MAUDE Adverse Event Report: K2M, INC. TL INTERBODY; SIZE 10X28X8 MM, 7; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 6101-2102808TL7-G2

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

Remains implanted.

Event Description

It was reported that after insertion and malleting, a cascadia tl interbody; size 10x28x8 mm, 7° disengaged and rotated intra-operatively.The device was left in the patient as the interbody was too difficult to remove.

Event Description

It was reported that after insertion and malleting, a cascadia tl interbody; size 10x28x8 mm, 7° disengaged and rotated intra-operatively.The device was left in the patient as the interbody was too difficult to remove.

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, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: in conjunction with the mallet, insert the implant into an oblique orientation across the disc space.Once in the oblique orientation, the implant can be disengaged from the inserter by turning the thumbwheel on the proximal end counter-clockwise.Entirely remove the inner shaft from the inserter while taking care to maintain the position of the distal tip of the inserter adjacent to the implant in the disc space.The inserter can now be used to tamp the implant into final position.It is recommended that the inner shaft remain threaded onto the interbody while malleting into disc space.It was reported that the inner shaft was removed prior to malleting the implant further into disc space.It is possible that the impaction force from malleting the unsecured implant caused the implant to prematurely disengage from the inserter.However, this root cause cannot be established conclusively as the device was not available for evaluation.

• Brand Name: TL INTERBODY; SIZE 10X28X8 MM, 7
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10102005
• MDR Text Key: 193071412
• Report Number: 3004774118-2020-00096
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 10888857160507
• UDI-Public: 10888857160507
• Combination Product (y/n): N
• PMA/PMN Number: K172009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6101-2102808TL7-G2
• Device Catalogue Number: 6101-2102808TL7-G2
• Device Lot Number: GKEK-32286
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1