MAUDE Adverse Event Report: TITAN SPINE UNKNOWN; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number MSB_UNK_CAGE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/11/2020

Event Type  Injury  

Manufacturer Narrative

D1, d4, g3: product identifiers & 510k are unknown 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.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 Description

Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding an event happened during post-op of the reported product.It was reported that, patient had pseudarthrosis and recurrence of pain table.Investigator assessment states, possibly related to procedure and ae not related to study device.Sponsor assessment states, possibly related to study procedure and not related to study device and study instruments.Were any diagnostic tests performed: yes  x-ray pseudarthrosis l5s1: yes ((b)(6) 2020) patient was hospitalized as a result of adverse event from 28/sep/2020 to 30/sep/2020.  concomitant medication administered or adjusted due to this adverse event: antalgics : paracetamol - birpofenid patient underwent additional surgery "arthrodesis" on (b)(6) 2020.  proximal instrumented vertebrae: l5.Distal instrumented vertebrae: s1 what is the outcome of this ae: recovered/resolved what date did the ae end: 28sep2020 no further complications reported as a result.No allegation/malfunction associated with the reported product.Arthrodesis surgery was performed on (b)(6) 2020.The investigator a ssessed this event as not related to study device and not related to the instruments.The sponsor assessed as possible relationship to the study device as l5-s1 was target level of the index study surgery.

• Brand Name: UNKNOWN
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): TITAN SPINE; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18243820
• MDR Text Key: 329433768
• Report Number: 3006340236-2023-00041
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_CAGE
• Device Catalogue Number: MSB_UNK_CAGE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 80 KG