MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number MSB_UNK_CAGE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

A2, a3: patient# 5 information populated b.3.Please note that this date is based off of the date that the article was available online as the event dates were not provided in the published literature.Angel e.Macagno., saqib hasan., cyrus m.Jalai., nancy worley., alexandre b.De moura., jeffrey spivak., john a.Bendo., peter g.P assias.¿¿¿¿reverse bohlman¿¿ technique for the treatment of high grade spondylolisthesis in an adult population¿.Journal of orthopaedics.Volume 13, issue 1, mar 2016, pages 1-9.Dx.Doi.Org/10.1016/j.Jor.2015.12.004.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

Angel e.Macagno., saqib hasan., cyrus m.Jalai., nancy worley., alexandre b.De moura., jeffrey spivak., john a.Bendo., peter g.P assias.¿¿¿¿reverse bohlman¿¿ technique for the treatment of high grade spondylolisthesis in an adult population¿.Journal of orthopaedics.Volume 13, issue 1, mar 2016, pages 1-9.Dx.Doi.Org/10.1016/j.Jor.2015.12.004 background/aims: surgical techniques for effective high-grade spondylolisthesis (hgs) re-main controversial.This study aims to eval uate radiographic/clinical outcomes in hgs patients treated using modified ¿¿reverse bohlman¿¿ (rb) technique.Methods: review of consecutive hgs patients undergoing rb at a single university-center from 2006 to 2013.Clinical, surgical, radiographic parameters collected.Results: six patients identified: five with l5-s1 hgs with l4-l5 instability and one had an l4-5 isthmic spondylolisthesis and grade 1 l5-s1 isthmic spondylolisthesis.Two interbody graft failures and one l5-s1 pseudoarthrosis.Postoperative improvement of anterolisthesis (62.3% vs.49.6%, p = 0.003), slip angle (10 vs.58, p = 0.005), and lumbar lordosis (49 vs.57.58, p = 0.049).Conclusions: rb technique for hgs recommended when addressing adjacent level instability/slip.Reportable event: there were two interbody cage failures.Patient #5 presented with pseudoarthrosis at l5-s1 and underwent a posterior revision surgery with extension of instrumentation to s1 and allograft harvested from b/l iliac crest one year after the initial procedure.The anterior titanium cage was not revised.At most recent follow-up, the patient was noted to be doing clinically well at 4 months postop, without early radiologic signs of complications.The other patient with interbody cage failure (patient #4) (fig.2) was instrumented posteriorly only at l4-l5.After the procedure, she did well initially but eventually developed recurrent severe pain.Imaging studies revealed fracture of the titanium cage at the disk space level, and fracture of the posterior fusion at the base of the l5 pedicle screws.Solid fusion was obtained after revision posterior surgery, which consisted of extension of instrumentation to the ilium with placement of a new titanium cage traversing l5 and s1 from posterior, similar to original bohlman technique, plus autograft.

• 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: 16883922
• MDR Text Key: 314711565
• Report Number: 1030489-2023-00337
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/10/2023
• 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: 39 YR
• Patient Sex: Male