MAUDE Adverse Event Report: TITAN SPINE, INC. ADAPTIX¿ INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	84332407
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare professional via a manufacturer representative regarding a patient with preoperative diag nosis for lumbar spondylolisthesis.Procedure performed was l4/5 mpplif, l5/s plif l4 to s2ai posterior fixation.Level at which the implant was performed was l4 to s2ai.Patient had a medical history of dialysis.It was reported that the patient had lower back pain.The lower back pain did not improve, so a ct scan was performed and back-out was confirmed.There were no neurological symptoms.Additional surgery performed as a result of this event was cage removal and bone grafting.Initial operation was performed in september 28.No pain at all 3 days after the first operation.Subsequently, the patient experienced lower back pain.It was assumed that the event was caused by a hematoma, and imaging tests were not performed immediately.After the examination, it was discovered that the cage had dislodged.At the time of the first operation, the right side was concave, and the cage itself did not move and fit perfectly.For dialysis patients, it was fixated without high risk of screw deviation due to compression.The rod was still inserted and it could be removed with a forcep.After that, the lamina was partially excised and transplanted between the vertebral bodies together with the autogenous bone in the cage.After the surgery, there was no special postoperative course, with a normal corset and ambulation from the day after surgery.No problems during surgery or immediately after surgery.
Additional Manufacturer Narrative
Radiographic image analysis has been done.Sagittal axial ct provided.On the axial ct image one of the interbody graft is located posteriorly in the spinal canal both grafts as per on the same side of the spine.Bone quality is poor.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADAPTIX¿ INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): TITAN SPINE, INC.; mequon research center; 6140a west executive drive; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE, INC.; mequon research center; 6140a west executive drive; mequon WI 53092
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 15705658
• Report Number: 3006340236-2022-00019
• Device Sequence Number: 6509080
• Product Code: MAX
• UDI-Device Identifier: 00763000202866
• UDI-Public: 00763000202866
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2022

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: Health Professional
• Device Model Number: 84332407
• Device Catalogue Number: 84332407
• Device Lot Number: TM0130445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 11/01/2022
• Date Device Manufactured: 01/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female