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

Model Number	84332809
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcomes to adverse event: other - pain.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The information was received from health care provider via a manufacturing representative regarding a patient with spinal therapy.It was reported that the cage was migrated and patient was brought back from the initial surgery completed on (b)(6) 2021 for a removal/ revision and replacement of the l5-s1 adaptix cage that was replaced with a capstone ptc cage.The revision surgery was completed today, (b)(6) 2021.Patient's initial surgery was completed on (b)(6) 2021.We had to remove and replace the l5-s1 tlif (adaptix cage) (28mm x 9mm) due to patient complaining of new leg pain.After completing a follow up ct scan.It was determined that the cage had migrated posteriorly and was aggravating the nerves.Dr.(b)(6) requested to use the "older technology" cage of capstone-ptc and increased the height to 10mm x 22mm cage (shorter length) at l5-s1.He also commented about the texture of the adaptix cage being much smoother then the capstone- ptc cages.There was no further complication reported.
Additional Manufacturer Narrative
Section e updated.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.
Event or Problem Description
The information was received from health care provider via a manufacturing representative regarding a patient with spinal therapy.It was reported that the cage was migrated and patient was brought back from the initial surgery completed on (b)(6) 2021 for a removal/ revision and replacement of the l5-s1 adaptix cage that was replaced with a capstone ptc cage.Please see previous description for cages sizes and additional details.The revision surgery was completed today.(b)(6) 021.Patient's initial surgery was completed on (b)(6) 2021.We had to remove and replace the l5-s1 tlif (adaptix cage) (28mm x 9mm) due to patient complaining of new leg pain.After completing a follow up ct scan.It was determined that the cage had migrated posteriorly and was aggravating the nerves.Dr.Schaible requested to use the "older technology" cage of capstone-ptc and increased the height to 10mm x 22mm cage (shorter length) at l5-s1.He also commented about the texture of the adaptix cage being much smoother then the capstone- ptc cages.There was no further complication reported.
Additional Manufacturer Narrative
H3:part # 84332809; lot # tm0127020 visual and optical inspection did not reveal any damage to the outer surface of the implant.The threads where the inserter connects have been damaged.Unable to determine root cause of implant migration.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, LUMBAR
• Manufacturer (Section D): TITAN MANUFACTURING; mequon WI 53223
• MDR Report Key: 11347388
• Report Number: 3006340236-2021-00003
• Device Sequence Number: 3343979
• Product Code: MAX
• UDI-Device Identifier: 00763000202996
• UDI-Public: 00763000202996
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2021

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: Health Professional
• Device Model Number: 84332809
• Device Catalogue Number: 84332809
• Device Lot Number: TM0127020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 02/02/2021; 05/22/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/02/2021; 05/31/2021
• 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
• Patient Age: 48 YR