MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG SEXTANT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number MSB_UNK_SCRW_SXT

Device Problem Migration (4003)

Patient Problem Spinal Column Injury (2081)

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.A3: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B3.Please note that this date is based off of the date of publication of article as the event dates were not provided in the published article.Product identifier is unknown multimodal applications of 3d-navigation in single-level minimally invasive transforaminal lumbar lnterbody fusion: impacts on precision, accuracy, complications, and radiation exposure arvind g.Kulkarni, pritem a.Rajamani, sandeep tapashetti, and tushar sathish kunder international journal of spine surgery, vol.16, no.4, 2022, pp.585-594 https://doi.Org/10.14444/8294 © international society for the advancement of spine surgery 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: three-dimensional (3d)-navigation in minimally invasive transforaminal lumbar interbody fusion (mitlif) is an evolving procedure.It is used not only for its accuracy of pedicle screw fixation but also for other major steps in transforaminal lumbar interbody fusion.Multimodal outcomes of this procedure are very limited in the literature.The purpose of this study was to examine the application of 3d-navigation in minimally invasive transforaminal lumbar interbody fusion (mi-tlif).Methods: a prospective study of 117 consecutive series of patients who underwent single-level lumbar mi-tlif with 3d-navigation operated by a single spine surgeon between january 2017 and july 2019 were evaluated.Among 117 patients, 6 patients were lost to follow-up and navigation registration failed in 9 patients.Therefore, 102 patients were included in the study.One hundred and two patients with a mean age of 60.2 years met the inclusion criteria.The mean presetting time of navigation was 46.65 ± 9.45 minutes.3d c-arm (siemens arcadis orbic3d) was used to retrieve the images.These images were uploaded onto the stealthstation using synergy (s-7) software (medtronic, minneapolis, usa).Transforaminal lumbar interbody fusion (tlif) was performed using a rigid 22-mm diameter tubular retractor (metrx tubular retractor system, medtronic sofamor danek, memphis, tn, usa).The percutaneous pedicle screw-rod systems utilized belonged to various sources such as sextant (medtronic sofamor danek, memphis, tn, usa), zimmer biomet (pathfinder nxt pedicle screw system, usa), globus medical (revolve, england), and jayon (mis monolock, india).Interbody fusions were performed using a titanium or polyetheretherketone cage and an autograft, the cage being precisely positioned with navigation assistance.The autograft consisted of local bone obtained from total facetectomy and laminotomy.Percutaneous pedicle screws were inserted using navigation assistance (ie, a tracker was attached to the handles of the tap and thepedicle screwdriver) over the preinserted guide wires (figure once all the pedicle screws were inserted, rods were introduced to connect the screws on each side and segmental compression was achieved under fluoroscopy guidance.Reported events pedicle screw breach was graded as grade o and grade 1 in 95.4% and 4.4% of patients, respectively.94.6% and 5.4% of pedicle screws demonstrated grade o and grade 1 cranial facet-joint violation.See attached literature article.

• Brand Name: SEXTANT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 16451267
• MDR Text Key: 310408988
• Report Number: 1030489-2023-00121
• Device Sequence Number: 1
• Product Code: NKB
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCRW_SXT
• Device Catalogue Number: MSB_UNK_SCRW_SXT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2023
• 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