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

Model Number	B33225512-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographic image review results are as per below - pre-op antero-posterior standing x-ray of scoliosis deformity.Unid lateral standing x-ray of pre-op plan.Lateral standing x-ray provided.No hardware present on provided images.This regulatory report is being submitted due to retrospective review through capa 624392.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information received from healthcare provider via manufacturer representative regarding an event happened during intra-op of a patient undergoing posterior and lateral spinal fusion.The pre-op diagnosis was adult scoliosis.It was reported that, one of the unid rod was broken when tried to bend the rod with french bender.The rod was broken outside the patient body.The unid rods were 5.5 cocr, and the broken rod was not implanted.The plan was to fuse patient¿s vertebrae from t10-pelvis by implanting lateral lumbar interbody fusion cages l2-l5.There were no fragments of broken rod were left inside the patient body.Surgeon didn¿t do enough bone work to loosen up the spine so the rod would fit.There were no patient symptoms or complications reported, no additional treatment or surgery performed as a result.

• 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: 21444607
• Report Number: 1000432246-2025-00010
• Device Sequence Number: 7158660
• Product Code: MNI
• UDI-Device Identifier: 03613720268635
• UDI-Public: 03613720268635
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/24/2025

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: B33225512-02
• Device Catalogue Number: B33225512-02
• Device Lot Number: 23C0477
• 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: 03/17/2023
• Initial Report FDA Received Date: 02/24/2025
• Date Device Manufactured: 03/14/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Male