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 Problems Neuropathy (1983); Pain (1994)

Event Type  malfunction  

Event Description

Summary:this study aims to investigate the relationship between endplate morphology parameters and the incidence of cage subsidence in patients with mini-open single-level oblique lateral lumbar interbody fusion (olif).Study included 119 inpatients who underwent olif from (b)(6) 2015 to (b)(6) 2017.A total of 119 patients with single treatment level of olif were included.Plain anteroposterior and lateral radiograph were taken preoperatively, postoperatively, and during follow-up.The correlation between disc height, endplate concave angle/depth, cage position and cage subsidence were investigated.Functional rating index (visual analogue scale for pain, and roland morris disability questionnaire) were employed to assess clinical outcomes.Results: cage subsidence was more commonly seen at the superior endplates (42/119, 35.29%) than at the inferior endplates (6/119, 5.04%) (p , 0.01).More importantly, cage subsidence was significantly less in patients with superior endplates that were without concave angle (3/20, 15%) than with concave angle (37/99, 37.37%) (p , 0.05).Cage subsidence correlated negatively with preoperative anterior disc height (r ¼ 0.21, p , 0.05), but positively with disc distraction rate (r ¼ 0.27, p ,0.01).Lastly, the distance of cage to the anterior edges of the vertebral body showed a positive correlation (r ¼ 0.26, p ,0.01).Conclusions: this study for the first time demonstrated that endplate morphology correlates with cage subsidence after olif.Since relatively flat endplates with smaller concave angle significantly diminish the incidence of subsidence, the morphology of cage surface should be taken into consideration when designing the next generation of cage.In addition, precise measurement of the disc height to avoid over-distraction, and more anteriorly placement of the cage is suggested to reduce subsidence.Reported events: among the 119 patients, 48 were confirmed to have cage subsidence, and pedicle screw fixation with/without posterior decompression was considered only for patients who were symptomatic (including recurrent or newly onset low back pain or radiculopathy).See attached literature article.

Manufacturer Narrative

The influence of endplate morphology on cage subsidence in patients with stand-alone oblique lateral lumbar interbody fusion (olif) ziang hu, md1, dengwei he, md2, jiawei gao, md2, zhongyou zeng, md3, chao jiang, md1, weiyu ni, ms1, jasper h.N.Yik, phd4, xing zhao, md1, and shunwu fan, md1 journals.Sagepub.Com/home/gsj.Event date: unknown.Product identifier is unknown.510(k)# is unknown.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.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: 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: 16680657
• MDR Text Key: 313235452
• Report Number: 1030489-2023-00244
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• 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: 03/08/2023
• 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