MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number 6069076

Device Problem Mechanical Problem (1384)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  malfunction  

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.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient implanted with cage having spinal therapy.It was reported that cages collapsed after surgery.The patient was symptom-free at the moment because of the loosening caused by the collapse.Implant remains in patient.There is no current plan to explant the cage.There were no further complications reported regarding the event.

Manufacturer Narrative

Updated information h6: patient codes (ime/annex e): pseudo arthrosis 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.

Event Description

Additional information received that collapse of the expanded cage led to a pseudo arthrosis witch made a revision surgery necessary on (b)(6) 2023.

Manufacturer Narrative

Radiographic image review results: l4-5 interbody fusion lateral x-ray interbody graft appears collapsed on right image compared to left image.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.

Manufacturer Narrative

Updated information :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.

Manufacturer Narrative

B5, b7, e: updated information 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.

Event Description

Additional information received that pre-op diagnosis was spondylolisthesis l4/5 with facet joint cyst and left type l5 neuro-compression.Surgery involved was navigated, minimally invasive spondylodesis l4/5 with mini-open tlif from left (catalyft pl 40 long, 7 mm expansive), intersomatic and posterolateral fusion.Patient was intubated and analgosedated in prone position on the operating table, compression-free abdomen.The pedicle was drilled with the navigated colibri, then secured with the kirschner wire, prepared with the thread cutter and then 7.0 x 55 mm pedicle screws of the type biedermann moss 100 were inserted in all four locations.The screws tighten well.Swivel in the surgical microscope and a facetectomy l4/5 with the 4 mm chisel and punches were performed.The cyst appears and is carefully removed.A cage of 7 mm height which is expansive was used.After insertion of autologous graft under serial x-ray, this cage was inserted, positioned, then lordotically was spread.The listhesis was reduced to a large extent, the hypolorotic segment has regained more lordosis.The nerves are decompressed on all sides.Intersomatically, the compartment was filled with autologous bone, then attached posterolaterally to the left and right.Tightening of the innies, termination of extensions and hemostasis had performed.Fascia s uture on both sides, leaving behind a redon drainage with slight suction subcutaneously, subcutaneous readaptation, disinfection and intracutaneous skin suture, and plaster dressing was followed later.Procedure was completed without complications lasting 185 minutes with a blood loss of less than 50 ml.Postoperatively, the patient had no longer has radicular pain and indicates an intact sensorimotor function.

• Brand Name: CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18434487
• MDR Text Key: 331826642
• Report Number: 1030489-2024-00014
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00763000246792
• UDI-Public: 00763000246792
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K210425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6069076
• Device Catalogue Number: 6069076
• Device Lot Number: 0965520W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Date Device Manufactured: 05/21/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 84 KG