MAUDE Adverse Event Report: MSD DEGGENDORF MFG CAPSTONE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number 2991232

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

Patient Problem Pain (1994)

Event Date 07/15/2023

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient with clinical id: (b)(6).It was reported that pain started in mid on (b)(6) as intermittent on the left side.Now progressed to constant "searing" pain that radiates into the left thigh.  severity of ae:  severe  diagnostics action type: diagnostic action subtype: x-ray 1 action result: stable posterior fusion from l3 to l5 dextroscoliotic curve multilevel disc disease and osteophyte formation no spinal instability with flexion or extension action date: on (b)(6)2023 action type: diagnostic action subtype: mri without contrast 2 action result: new left sided lateral recess and foraminal disc extrusion at l2-3 with disc material extending superiorly along the posterior aspect of l2 to the upper part of l2.Severe canal narrowing on the left.Action date: on (b)(6) 2023 action type: diagnostic  interventions action subtype: ae result in hospitalization action result: n  action subtype: any other action(s) taken action result: n  action subtype: did the ae result in any treatment action result: y  action subtype: physical therapy action result: yes  action subtype: surgical treatment action result: yes  outcome status recovering/resolving  site related assessment:  possibly related to capstone peek spinal system implant, tlif grafting material, and tlif procedure.Unlikely related to posterior supplemental fixation system.  primary diagnosis: stenosis  on (b)(6) 2021, l3-l4 and l4-l5 open surgical access; facets decorticated; side of interbody placement insertion - superior treated level : left; side of interbody placement insertion - inferior treated level : left; volume of local bone autograft implanted - superior treated level : 20 cc; volume of allograft bone implanted (if needed to supplement local bone autograft) - superior treated level : 20 cc; total estimated blood loss : 300 ml mdt relatedness to procedure- not related to products or procedure there were no further complications reported regarding the event.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 2990832, serial/lot#: (b)(6), ubd: 28-feb-2028, udi#: (b)(4), h6: 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.

Event Description

Mdr decision corrected to not reportable.No additional supplemental reports will be required unless additional information received indicates reportable event.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunction.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CAPSTONE SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469 ; GM 94469
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18571643
• MDR Text Key: 333610514
• Report Number: 1030489-2024-00060
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00613994290946
• UDI-Public: 00613994290946
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2991232
• Device Catalogue Number: 2991232
• Device Lot Number: H5651628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• Date Device Manufactured: 01/26/2021
• 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
• Treatment: "SEE H10."
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Race: White