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

Model Number MSB_UNK_SCREW

Device Problem Malposition of Device (2616)

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

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

Average age of patients is 64, average gender of patients was female, product identifiers not available, since product identifiers are unknown, 510k# is not available,guang-xun lin, kutbuddin akbary, vit kotheeranurak, javier quillo-olvera, hyun-jin jo, xiao-wei yang, akaworn mahatthanatrakul, jin-sung kim.Clinical and radiologic outcomes of direct versus indirect decompression with lumbar interbody fusion: a matched-pair comparison analysis.World neurosurg.(2018) 119:e898-e909.Doi.10.1016.2018.08.003 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: mi techniques for tlif as well as oblique lateral interbody fusion (olif) have been used in fusion of the lumbar spine due to the development of surgical armamentarium.Between april 2012 and january 2017, a total of 104 patients were operated by olif and 144 patients underwent mi-tlif by a single surgeon (j.S.K.).Patients who underwent surgery at the l4el5 level for either low-grade spondylo listhesis or lumbar spinal stenosis with symptoms of radicular pain and neurogenic intermittent claudication with mechanical low back pain were selected, in whom more than 6 months of conservative treatment had failed to relieve their symptoms.All patients had no previous history of lumbar surgical intervention at the l4el5 level, and patients who completed a minimum of 12 months of follow-up were included.In the olif group, 36 of 104 patients underwent single-level olif at l4el5 and 11 of them were excluded from this study because of severe stenosis requiring additional posterior decompression.Finally, only 25 patients who underwent olif without laminectomy were enrolled.In the mi-tlif group, 53 of 144 patients underwent single-level mi-tlif at l4el5 using a single cage¿14 patients with the use of banana-shaped cage and 39 patients with the use of straight cage.25 of 39 patients in mi-tlif group matched pairs with 25 patients of olif group were selected in terms of demographic data, preoperative clinical parameters, and radiologic parameters.Among the 39 patients, 14 patients who were not included in the current study also had good surgical outcomes and similar complications compared with the 25 patients who were enrolled.In other words, these 14 patients could be replaced by the patients who were already included in this study when meeting the matching principle of this study.The all patients who initially underwent the olif procedure had an insertion of a cage (20 cases with a 6 cage and 5 cases with a 12 cage [clydesdale; medtronic sofamor danek, memphis, tennessee, usa]) filled with demineralized bone matrix.Iliac bone or bone morphologic protein was not used for the interbody fusion in any of the patients.None of the patients underwent additional laminectomy at the index level.In the mi-tlif group, all patients underwent unilateral mi-tlif surgery using a microscope, and a straight cage was inserted (all cases with a 0 cage [opal; depuy-synthes spine, raynham, massachusetts, usa or capstone; medtronic sofamor danek, memphis, tennessee, usa]) filled with demineralized bone matrix and local autograft bone obtained from unilateral total facetectomy.Reported events: the total complication rate was 36% in the olif group and 32% in the mi-tlif group (p ¼ 0.77) (table 4).In the olif group, 8 of 25 patients had 9 complications.There was 1 patient who had both sympathetic injury and leg numbness that were transient in nature and improved with observation at the 3-month follow-up.One case of l4 segmental artery injury was noticed intraoperative and immediate hemostasis was achieved by using a hemoclip.One patient complained of leg pain/numbness at 23 months after surgery and an open tlif (l5es1) for adjacent-segment disease was performed.Other transient complications included 4 incidences of leg numbness and 1 incidence of sympathetic chain injury, which were managed by observation and recovered within 3 months in the postoperative period.In the mi-tlif group, 6 of 25 patients had 8 complications.One patient had 3 complications: dural tear, pulmonary thromboembolism, and deep-vein thrombosis was further managed and treated by the cardiology department.One patient with thrombocytopenia was treated solely by observation.Two incidences of asymptomatic screw malposition were observed.Two cases of leg pain/numbness were resolved within 3 months in the postoperative period by conservative management.The incidence of approach related-complications after olif seems relatively high (32%) compared with mi-tlif (20%) but did not reach statistical significance (p ¼ 0.33).Medtronic product involved in this event is a screw.

• Brand Name: UNKNOWN
• 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: 15072998
• MDR Text Key: 297488080
• Report Number: 1030489-2022-00669
• 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: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCREW
• Device Catalogue Number: MSB_UNK_SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/21/2022
• 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: 64 YR
• Patient Sex: Female