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

Model Number	B33225512-02
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2.Revision surgery scheduled.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
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having revision poster ior spinal fusion and posterior spinal instrumentation t11 to the pelvis.Pre-op diagnosis: bilateral l4-5 foraminal stenosis (stable compared to march ct), right l5-s1 foraminal stenosis (also stable compared to (b)(6)) and bilateral si joint arthritis.It was reported that the patient had initial surgery on (b)(6) 2023 and experienced low back pain and leg pain post-operatively, right greater than left.The unid rod was fractured at the level of the s1 screw on the left side and the right iliac screw was fractured.It is unknown if the screws are of medtronic products.There is a possibility of broken hardware stressing the bone.The patient is scheduled for a revision surgery on (b)(6) 2025 due to low back pain and rod fracture.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
Additional information: b2, d6b, h6, h11 radiographic image review: the ap x-ray of t11-sacroiliac fusion was provided.Multiple rods present.Screw fracture at iliac in right panel and rod fracture at l5-s1 in left panel was noted.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.It was reported that the additional surgery was performed (b)(6) 2025 successfully and the broken rod was explanted.

• 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: 21705744
• Report Number: 1000432246-2025-00015
• Device Sequence Number: 18644663
• Product Code: MNI
• UDI-Device Identifier: 03613720268635
• UDI-Public: 03613720268635
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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 Model Number: B33225512-02
• Device Catalogue Number: B33225512-02
• Device Lot Number: 23C0096
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/22/2025
• Date Device Manufactured: 03/02/2023
• 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: Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 96 KG