MAUDE Adverse Event Report: MEDICREA INTERNATIONAL SA MEDICREA LEGACY TL; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	B242C12062810
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415); Inadequate Osseointegration (2646)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient's husband regarding a patient having spinal therapy.It was reported that the patient had leg numbness and back pain.The cage has moved since surgery and screws loosening were reported.There were no further complications reported regarding the event.Additional information was received regarding the event.Patient's spouse reported that his wife is having leg numbness on left side and leg weakness and experiencing nerve pain from lower back to her hip down her leg to her toes.She can¿t stand for a long period of time due to weakness.The patient had her first surgery on (b)(6) 2021 and also had a 2nd surgery on (b)(6) 2024 which was a revision surgery.The reason for revision surgery is unknown.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
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 or Problem Description
Additional information was received regarding the event.The patient had non-fusion, migration of cage and broken screws.The patient did not have any pain relief after her index surgery performed on (b)(6) 2021.Due to persistent pain, the patient switched to a new surgeon and underwent a revision surgery on (b)(6) 2024.The old screws were removed in additional surgery but left the old cage in and added new screws and cages.The patient is doing well now.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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: MEDICREA LEGACY TL
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer (Section G): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 20366430
• Report Number: 1000432246-2024-00019
• Device Sequence Number: 3689107
• Product Code: MAX
• UDI-Device Identifier: 03613720270546
• UDI-Public: 03613720270546
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K163595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2023
• Device Model Number: B242C12062810
• Device Catalogue Number: B242C12062810
• Device Lot Number: 18D0709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 10/25/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/01/2024; 11/19/2024
• Date Device Manufactured: 05/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown