MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number MSB_UNK_CAGE

Device Problem Migration (4003)

Patient Problem Stenosis (2263)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.Yoshihisa kotani , yoshinao koike, atsushi ikeura, hirohiko tokunaga, takanori saito clinical and radiologic comparison of anterior-posterior singleposition lateral surgery versus mis-tlif for degenerative lumbar spondylolisthesis journal of orthopaedic science , https://doi.Org/10.1016/j.Jos.2020.10.013 d6a.The date range for surgical procedures is between 2013 to 2018 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 Description

Summary : a total of 142 patients underwent either olif-lpf (92 cases) or mis-tlif (50cases) for l3 or l4 ds.The olif-lpf was performed in right decubitus position with allograft and percutaneous modified cortical bone trajectory screws (mcbt).The mis-tlif utilized a single 4 cm midline incision, allograft, boomerang cage and mcbts.The operation time, estimated blood loss, and serum crp levels were recorded.Joabpeq effectiveness rate (%), visual analogue scale (vas), fusion rate, segmental radiologic alignment, and complications were also evaluated.Reported events: ¿ one patient in olif-lpf demonstrated the occurrence of lateral disc herniation at adjacent spinal segment, which was conservatively treated.¿ one patient exhibited olif cage sinking causing stenotic symptom temporarily, which was conservatively treated and resolved.¿ the multiple sclerosis occurred in one patient in olif-lpf after a few months postoperatively, who was transferred to neurology unit.¿ the pseudarthrosis was detected in three patients of olif-lpf which was conservatively treated.¿ the symptomatic adjacent segment disease (asd) was detected in seven patients of olif-lpf.¿ the additional fusion surgeries were required in three patients in olif-lpf which was due to asd.See attached article.

• Brand Name: UNKNOWN
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 15052141
• MDR Text Key: 304719999
• Report Number: 1030489-2022-00667
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/22/2022
• 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 Age: 72 YR
• Patient Sex: Female