MAUDE Adverse Event Report: MSD DEGGENDORF MFG UNKNOWN; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number MSB_UNK_HDWR_CDH

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

Patient Problems Pain (1994); Stenosis (2263)

Event Date 08/01/2023

Event Type  Injury  

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having l3/l5 tlif for an indication of stenosis.It was reported that the patient developed radiating pain secondary to severe left foraminal stenosis at l5/s1 and degenerative leftward tilt at l5/s1.Mri on (b)(6) 2023: facet arthropathy, ligamentum thickening, moderate central canal stenosis, severe right and moderately severe left foraminal narrowing at l5/ s1.L2/l3 moderately severe central stenosis, moderate bilateral foraminal stenosis.The patient is scheduled for removal of hardware at l3/l5 with tlif at l2/l3 and l5/s1 and posterior fusion l2/s1.There were no further complications reported regarding the event.Additional action taken: l5/s1 esi ordered.The ae resulted in additional treatment with physiatrist.Outcome status: recovering/resolving.The patient underwent diagnostics test of mri with contrast2 on (b)(6) 2023. action result: l2/l3 and l5/s1 central and foraminal ste nosis.The patient underwent diagnostics test of x-ray1 on (b)(6) 2023. action result: upper lumbar mild spondylosis.Site related assessment: the event is probably related to capstone peek spinal system, posterior supplemental fixation system, tlif grafting material and study procedure.Sponsor assessment: unlikely related to procedure.Possible relationship to tlif grafting material, intervertebral body fusion and posterior supplemental fixation system.Additional information was received regarding the event.It was reported that there was no device malfunction reported.There were no further complications reported regarding the event.The patient had right lumbar radiculopathy.Procedure: l3/l5 tlif.Medical iintervention: yes action subtype: surgical treatment, action result: yes.Add surgical procedure date: (b)(6) 2023 details surg procedure: l2/l3 and l5/s1 tlif for posterior instrumentation removal at l3-l5 with posterolateral arthrodesis, segmental instrumentation at l2/s1.Is the additional surgical procedure an elective removal: yes, adjacent levels tlif and segmental instrumentation.Were the index treated level(s) fused prior to the elective removal of the fixation component of the original surgical construct: yes.Does the additional surgical procedure involve a spinal level: yes.Additioanl surgery levels involved: l2-l3, l3-l4, l4-l5, l5-s1.Does the additional surgical procedure involve an explant related to the study procedure: yes cause of explantation: adjacent level decompression and fusion.Findings for explantation: severe stenosis at l2/l3 and l5/s1 due to degenerative tilt of l3, l4, l5 into the sacrum on the right.Findings at additional surgery: solid evidence of fusion at l3/l5.Biopsies taken: no the site assessed as possibly related to capstone peek spinal system implant and posterior supplemental fixation system and probably related to procedure and not related to tlif grafting material.Additional information was received regarding the event.The patient underwent removal of hardware at l3/l5 with tlif at l2/l3 and l5/s1 and posterior fusion l2/s1 on (b)(6) 2023.Hospitalization: yes additional information was received regarding the event.Action taken: l5/s1 esi ordered; using bone growth stimulator.(b)(6) 2023: patient has minimal pain after his surgery on (b)(6) 2023,off all pain medications, has brace and bone growth stimulator, his right lower extremity symptoms resolved.

Manufacturer Narrative

H3: 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.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.

• Brand Name: UNKNOWN
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 18127925
• MDR Text Key: 327998010
• Report Number: 1030489-2023-00758
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_HDWR_CDH
• Device Catalogue Number: MSB_UNK_HDWR_CDH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Date Device Manufactured: 08/26/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White