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 Muscle Weakness (1967); Neuropathy (1983); Paresthesia (4421)

Event Date 04/22/2022

Event Type  malfunction  

Event Description

Arvind g.Kulkarni, pritem a.Rajamani, sandeep tapashetti, tushar sathish kunder "multimodal applications of 3d-navigation in single-level minimally invasive transforaminal lumbar interbody fusion: impacts on precision, accuracy, complications, and radiation exposure" international journal of spine surgery 2022, vol.16, no.4, 2022, pp.585¿594, doi.Org/10.14444/8294.Summary: patients who underwent single-level mi-tlif using 3d-navigation between january 2017 and july 2019 were evaluated for navigation setting time, radiation exposure, volume of nucleus pulposus excised, cage placement, accuracy of pedicle screw placement, and cranial facet-joint violation.Reported events: one hundred and two patients with a mean age of 60.2 years met the inclusion criteria.The studygroup had 44 men (n = 44) and 58 women (n = 58) with an average age of 60.2 years (46¿74 years).3d c-arm was used to retrieve the images.These images were uploaded onto the stealthstation using synergy (s-7) software.Transforaminal lumbar interbody fusion (tlif) was performed using a rigid 22-mm diameter tubular retractor r (metrx tubular retractor system).The patients were positioned prone and the 3d c-arm was triggered to spin around the patient and images were then transferred to the stealth monitor.The surgical microscope was moved into the field and decompression and interbody fusion was performed through the tubular retractor with variations in the operative steps as per the demands of the indication.Discectomy and disc space preparation was performed with the help of disc forceps, kerrison rongeurs, bayonetted curettes, and rotating endplate shavers.The superior and inferior endplates were grated in all possible trajectories.Interbody fusions were performed using a titanium or polyetheretherketone cage and an autograft, the cage being precisely positioned with navigation assistance.5.Percutaneous pedicle screws were inserted using navigation assistance.Once all the pedicle screws were inserted, rods were intro duced to connect the screws on each side and segmental compression was achieved under fluoroscopy guidance.The wound was then closed in layers.Total navigation setting time, radiation exposure, volume of nucleus pulposus excised, cage placement, pedicle screw br each, and cranial facet-joint violation were determined.The current study included a total of 408 pedicle screws implanted in 102 patients.The cage position was central in 87 patients, contralateral anterocentral in 6 patients, and ipsilateral posterocentral in 8 patients, respectively.Progressive posterior cage migration was noticed in a patient with initial posterolateral placement of the cage and this was corrected.Pedicle screw breach was graded as grade 0 and grade 1 in 95.4% and 4.4% of patients, respectively.Again, 94.6% and 5.4% of pedicle screws demonstrated grade 0 and grade 1 cranial facet-joint violation, respectively.In one case, a grade 3 pedicle screw breach occurred.This was suspected intraoperatively while examining the c-arm images and confirmed by spinning the 3d c-arm again and extracting images before extubating the patient.This was probably due to a technical error and was immediately corrected.This was the same patient whose cage had migrated posteriorly, which had to be corrected.Postoperatively, the patient had paresthesia in the foot over l5 dermatomal distribution and weakness in ankle dorsiflexion.While the foot weakness resolved completely after 3 months, the paresthesia resolved only partially, and at their last follow-up, the patient complained of allodynia.

Manufacturer Narrative

Arvind g.Kulkarni, pritem a.Rajamani, sandeep tapashetti, tushar sathish kunder "multimodal applications of 3d-navigation in single-level minimally invasive transforaminal lumbar interbody fusion: impacts on precision, accuracy, complications, and radiation exposure" international journal of spine surgery 2022, vol.16, no.4, 2022, pp.585¿594, doi.Org/10.14444/8294.Patient age: this value is the average age of the patients reported in the article as specific patients could not be identified.Patient sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Event date: please note that this date is based off of the date of publication of the article.Product identifiers are unknown.Report source: country: india.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: 16331097
• MDR Text Key: 309178397
• Report Number: 1030489-2023-00072
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• 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: 01/20/2023
• 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 Age: 60 YR
• Patient Sex: Female