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

Model Number	84332814
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient previously implanted with 2 cages in a 2 level lumbar fusion on (b)(6) 2021 at l3/l4 and l4/l5.It was reported that the patient had back pain in the week of (b)(6) 2022.Scan showed one of the 2 interbody cages (adaptix cage) migrated posteriorly.The surgeon performed an explant of the migrated interbody cage on (b)(6) 2022.The patient had fallen several times (6 times).According to the surgeon¿s opinion, the fall led to the cage migration.The other cage at l3/l4 was still in place.The surgeon replaced 4 of the 6 screws that were loose due to the patient¿s numerous falls and re-applied the rods with new set caps.The patient was going to be discharged to an assisted living arrangement.There were no further complications reported regarding the event.

• 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
• Manufacturer (Section G): TITAN SPINE, INC; mequon research center; 6140a west executive drive; mequon WI
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13567431
• Report Number: 3006340236-2022-00003
• Device Sequence Number: 17658051
• Product Code: MAX
• UDI-Device Identifier: 00763000203047
• UDI-Public: 00763000203047
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K201267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2022

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: 84332814
• Device Catalogue Number: 84332814
• Device Lot Number: TM0128106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/21/2022
• Date Device Manufactured: 09/29/2020
• 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 Age: 75 YR
• Patient Sex: Male