MAUDE Adverse Event Report: TITAN SPINE, INC. MEQUON RESEARCH CENTER ENDOSKELETON¿ TL INTERBODY SYSTEM; DRIVER, PROSTHESIS

Model Number	7200-1004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Information was received from a healthcare professional (hcp) via a medtronic representative regarding an inserter and blades used in an olif 2-5 at 3 levels for ddd.It was reported that upon retraction using the olif anterior blades sizes 15 and 17, the blades bent under retraction and the surgeon requested that the size 15 and 17 blades be replaced as the concern was that the metal was weakening.Upon inserting the titan tl cage, the inserter prongs that fit inside the cage broke off.The loose pieces from the inserter were retrieved and discarded and the inserter was passed off the field for repair.There were no patient symptoms or complications as a result of this event.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
H3: product analysis part# 200-1004 ; lot# l200901- visual exam and microscopic exam show that the tabs of the instrument is completely sheared off and the threaded inner shaft is missing.The broken piece was not returned for the analysis.This is consistent with bend stress overload.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: ENDOSKELETON¿ TL INTERBODY SYSTEM
• Common Device Name: DRIVER, PROSTHESIS
• 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: 16617339
• Report Number: 3006340236-2023-00011
• Device Sequence Number: 7305502
• Product Code: HWR
• UDI-Device Identifier: 00191375009269
• UDI-Public: 00191375009269
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7200-1004
• Device Catalogue Number: 7200-1004
• Device Lot Number: L200901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown