MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number MSB_UNK_SCRW_SXT

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2022

Event Type  Injury  

Manufacturer Narrative

Patient age: average age was 61.4 years (range, 53-69.8 years).Patient sex - 41 male and 67 female (total of 108 patients) event date: please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.Report source: country - south korea.Device eval by mfr: 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.Citation: ji-won kwon, yung park, byung ho lee, so ra yoon, joong-won ha, hyunkyo kim, kyung-soo suk, seong-hwan moon, hak-sun kim and hwan-mo lee.Ten-year outcomes of minimally invasive versus open transforaminal lumbar interbody fusion in patients with single-level lumbar spondylolisthesis.A retrospective observational study.Spine surgery.2022.Spine volume 47, number 11, pp 773¿780.Doi: 10.1097/brs.0000000000004334.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

Citation: ji-won kwon, yung park, byung ho lee, so ra yoon, joong-won ha, hyunkyo kim, kyung-soo suk, seong-hwan moon, hak-sun kim and hwan-mo lee.Ten-year outcomes of minimally invasive versus open transforaminal lumbar interbody fusion in patients with single-level lumbar spondylolisthesis.A retrospective observational study.Spine surgery.2022.Spine volume 47, number 11, pp 773¿780.Doi: 10.1097/brs.0000000000004334.Event summary: the study is the retrospective collection of the outcome data of patients with single-level lumbar spondylolisthesis who underwent tlif procedures using an mi (108) approach.52 (48%) patients in the mi-tlif completed the 10-year follow-up. from march 2003 to december 2009, 124 consecutive patients with low-grade spondylolisthesis and degenerative lumbar diseases who underwent tlif (performed by a single surgeon with at least 10 years of post-fellowship surgical experience).Initial diagnoses included single-level degener ative and spondylolytic spondylolisthesis. from march 2003 to december 2007, consecutive patients who were diagnosed with single-level spondylolisthesis underwent mi-tlif were included in this study. the study included 108 patients (33 isthmic spondylolisthesis and 75 degenerative spondylolisthesis) who underwent l3-l4, l4-l5 and l5-s1 mi-tlif (67 female, 41 male andmean age, 61.4+/-8.4 yrs). postoperative adverse events were defined as events related to complications of spinal surgery within the perioperative (from the day of surgery to 12 weeks operatively) and postoperative (beyond 12 weeks after surgery) periods that required non-surgical treatment until additional surgery was eventually performed.Reported events: the reoperation was performed in 2 patients for the screw misplacement.One patient underwent reoperation for cage migration.Cage migartion was reported in 1 patient.Cage subsidence was reported in 2 patients.The reoperation was performed for grafted bone extrusion in 1 patient and deep wound infection in 1 patient.Second surgeries due to symptomatic asd within the 2-year postoperative period in 2 patients , within the 5-year postoperative period in 7 patients and within the 10-year postoperative period in 14 patients.One patient had dural tears and six patients had postoperative neurologic deficit.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 16671753
• MDR Text Key: 312593689
• Report Number: 1030489-2023-00233
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• 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: 03/09/2023
• 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: 62 YR
• Patient Sex: Female