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

Model Number	B33226012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: the country of the event is france.H11.Radiographic image review indicated that the ap standing scoliosis x-ray and lateral x-ray of same was provided.No hardware present.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 posterior corre ction with screw and rods for an indication of scoliose idiopathique - niveaux t2-l1 - tiges cocr 6 - cyphose t4-t12 30° - pourcentage de correction 80%.It was reported that one convex rod broke during correction for moderate deformation.There was no patient symptom reported.There were no further complications reported regarding the event.

• 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: 20608213
• Report Number: 1000432246-2024-00021
• Device Sequence Number: 18183724
• Product Code: MNI
• UDI-Device Identifier: 03613720205883
• UDI-Public: 03613720205883
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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: B33226012
• Device Catalogue Number: B33226012
• Device Lot Number: 24I0504
• 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: 10/09/2024
• Initial Report FDA Received Date: 11/05/2024
• 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: 13 YR
• Patient Sex: Female