MAUDE Adverse Event Report: K2M, INC. TL INTERBODY; SIZE 10X32X11 MM, 7; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6101-2103211TL7-G2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that a cascadia tl interbody fractured post-operatively.The patient presented with pain 6 months post op.A ct scan was performed and it was discovered that cage was shattered.The patient is being treated conservatively with pain management.There are no plans for revision surgery at this time.
Additional Manufacturer Narrative
Correction to b2: corrected from 'required intervention to prevent permanent impairment/damage (devices)' to 'other serious (important medical events)'.Functional, dimensional, and material analysis could not be performed as the device was not available because it remains implanted in the patient.However, x-rays were provided and upon review, it was confirmed that the cage was shattered.A haloing effect can be observed, indicating fusion had taken place.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.It was reported that the patient had a very collapsed disc space.Inserting/impacting a large interbody in a tight disc space may have caused damage to the interbody.It is likely that microfractures during insertion, coupled with pressure from the upper and lower vertebral bodies, caused the interbody to shatter.
Event or Problem Description
It was reported that a cascadia tl interbody fractured post-operatively.The patient presented with pain 6 months post op.A ct scan was performed and it was discovered that cage was shattered.Fusion is in the process of being achieved, however, there are no plans for revision surgery at this time.The patient is being treated conservatively with pain management and will continue to be monitored.
Additional Manufacturer Narrative
Outcomes attributed to ae b.2.Has been corrected from 'other serious' to "required intervention' additional information confirmed that the patient has been revised.The investigation has been reopened and is still in process.We will communicate our findings regarding the cause of this event in our final report.
Event or Problem Description
It was reported that a cascadia tl interbody fractured post-operatively.The patient presented with pain 6 months post op.A ct scan was performed and it was discovered that cage was shattered.The patient has been revised.
Event or Problem Description
It was reported that a cascadia tl interbody fractured post-operatively.The patient presented with pain 6 months post op.A ct scan was performed and it was discovered that that cage was shattered.The patient has been revised.
Additional Manufacturer Narrative
Visual inspection: x-rays were provided by the rep.Upon review, it was confirmed that the cage was shattered.A haloing effect can be observed, indicating fusion had taken place.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The device was not returned and was therefore unavailable for evaluation.However, the incident was confirmed through analysis of radiographic images.It was reported that the patient had a very collapsed disc space.Inserting/impacting a large interbody in a tight disc space may have caused damage to the interbody.It is likely that microfractures during insertion, coupled with pressure from the upper and lower vertebral bodies, caused the interbody to shatter.H3 other text : status and location of the device is unknown.

• Brand Name: TL INTERBODY; SIZE 10X32X11 MM, 7
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10339967
• Report Number: 3004774118-2020-00154
• Device Sequence Number: 3749122
• Product Code: MAX
• UDI-Device Identifier: 10888857160804
• UDI-Public: 10888857160804
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K172009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 6101-2103211TL7-G2
• Device Catalogue Number: 6101-2103211TL7-G2
• Device Lot Number: JVRG-388571
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/04/2020; 09/30/2020; 01/26/2021
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/01/2020; 10/29/2020; 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention