MAUDE Adverse Event Report: MEDICREA INTERNATIONAL SA UNID ROD; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	B33125512-02
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having t10-ileum spinal fusion for an indication of flat back syndrome, radicular pain, post surgical arthrosis and low back pain.It was reported that during measuring the post op x-ray, it was noticed that the rod was fractured.There was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
Radiographic image review: the ap-x-ray of tlsi fusion was provided.The rod is fractured on one side at the lumbo sacral junction.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: UNID ROD
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• 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: 21271600
• Report Number: 1000432246-2025-00007
• Device Sequence Number: 19819284
• Product Code: MNI
• UDI-Device Identifier: 03613720268468
• UDI-Public: 03613720268468
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K140738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: B33125512-02
• Device Catalogue Number: B33125512-02
• Device Lot Number: 22C0532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/30/2025
• Date Device Manufactured: 03/18/2022
• 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
• Patient Age: 87 YR
• Patient Sex: Male