MAUDE Adverse Event Report: K2M, INC. TL INTERBODY; SIZE 12X36X13 MM, 7; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6101-2123613TL7-G2
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
A cascadia cage was implanted during index surgery and instrumented with the cayman plate.The patient started to have returning symptoms of back pain and le dysesthesias.There is a potential for revision surgery.This record represents the cage.
Additional Manufacturer Narrative
Corrections were mad to d3 & g1: updated from 'stryker spine-leesburg' to 'k2m, inc'.Visual, functional, material, and dimensional analysis were unable to be performed since the device was never returned for investigation.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Cascadia tl surgical technique was reviewed and the following relevant information was identified: the surgeon should adequately instruct the patient that postoperative care and the patient's ability and willingness to follow instructions are two of the most important aspects of successful healing.The surgeon should also inform the patient about potential postoperative adverse consequence as internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Periodic x-rays for at least the first year postoperatively are recommended for close comparison with postoperative conditions to detect any evidence of changes in position, nonunion, loosening, and bending or cracking of components.With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of reduced activity and/or early revision considered.It is not clear if there was a traumatic event or another catalyst which triggered the adverse event.No evidence of a device malfunction was communicated and it is unclear what failure modes, if any, had occurred.As a result, no root cause for the adverse event could be determined based on the available information.
Event or Problem Description
A cascadia cage was implanted during index surgery and instrumented with the cayman plate.The patient started to have returning symptoms of back pain and le dysesthesias.There is a potential for revision surgery.This record represents the cage.

• Brand Name: TL INTERBODY; SIZE 12X36X13 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: 9158675
• Report Number: 3004774118-2019-00117
• Device Sequence Number: 16781611
• Product Code: MAX
• UDI-Device Identifier: 10888857269811
• UDI-Public: 10888857269811
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172009
• 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
• Report Date (Section B): 03/24/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 6101-2123613TL7-G2
• Device Catalogue Number: 6101-2123613TL7-G2
• Device Lot Number: EPEX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 02/29/2020
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 03/24/2020
• 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